India Certification made easy

With its many independent authorities and processes, the certification landscape in India is quite a challenge to navigate. Do you need AIS/TAC, BIS, TEC, WPC, CDSCO or PESO registration or want to find out whether you need it? With us as your professional partner you can safely and easily obtain your India certification.

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AIS – Automotive Industry Standard

India Certification is an excellent partner for the AIS/TAC certification in the automotive sector. We are providing leading automotive suppliers and car manufacturers with quick and smart solutions for their TAC certification. We offer you our support for every project related to the Automotive AIS.

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BIS – Bureau of Indian Standards

India Certification is an excellent partner for the BIS certification for electronic products. The list of products requiring accreditation is extended regularly. We are providing leading manufacturers with quick and smart solutions for their India certification. With us you will navigate the Indian certification landscape safely.

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TEC – Telecommunication Engineering Center

India Certification is an excellent partner for the TEC certification for telecom equipment. Certification requirements change constantly and the list of products that require TEC approval is extended regularly. We will identify certification requirements of your product and make sure that you will obtain your TEC registration swiftly and reliably.

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WPC – Wireless Planning & Coordination Commission

India Certification is an excellent partner for the WPC certification for wireless products. We will clarify if certification is necessary for your product and if yes, what test requirements exist. We will ensure that tests are conducted correctly and that you will obtain your WPC registration swiftly and reliably.

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CDSCO

Medical devices and pharmaceuticals need CDSCO approval before they can be sold in India. We offer the evaluation of CDSCO classifications (Classes A – D) for your medical device and guide you through the complete CDSCO approval processes.

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We offer many other certifications and services for the Indian and many other markets. Whether one of the certifications for the Automotive, Electronics or Telecommunications industries, the approval for a medical product, or even just a temporary shipment for other purposes: We support you throughout the entire process.

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India Certification provides a range of specialized consulting services, especially for car manufacturers and large industrial companies. With the consulting packages the certifications as well as internal procedures related to international product certifications can be streamlined.

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India Certification offers customized certification training to fit your company needs. Our trainer will come to your location and provide the training, up to date information and pass on valuable tips from our many years of experience. Call us today to learn more!

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Since 2005, India Certification (MPR International GmbH) has been supporting companies around the world in obtaining the required product certifications for the Asian markets. With a strong team located worldwide, we can offer you the best solution for your enquiries.

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Certification Mandatory Products

The list of medical products that are required to be CDSCO approved is very long and regularly extended.

A simple principle to consider when determining need is:

A medical device is any product that is intended to be used alone or in combination with another product, in the diagnosis of diseases or in the cure, mitigation, treatment, or prevention of diseases, injuries, life support, contraception, in humans or other animals.

For more information regarding the CDSCO certification, please read our free information booklet “CDSCO Registration – The Booklet“.

Classification of Newly Notified Medical Devices

 

S. No. Notified Category Intended Use Risk Class
 

1.

CT scan Equipment Use of x-ray source and digitally scanned computer technology to create cross-sectional images of the body. Class C
 

 

2.

 

MRI

Equipment

It is a medical imaging procedure using radio waves, magnetic fields, and magnetic field gradients to generate images of organs in the body.  

Class C

 

 

3.

 

Defibrillators

It is a device that automatically analyzes the rhythm of heart of cardiac arrest patients and delivers an electrical shock to the heart for restoring the normal rhythm of heart.  

Class C

 

4.

Dialysis Machine It is used for acute or chronic kidney failure that filters blood to remove excess water and waste products.  

Class C

 

 

5.

 

PET

Equipment

Intended to detect the gamma radiation and positron emitting radionuclides in the body and produce cross-sectional images which reflect the distribution in the body or individual organs.  

Class C

 

 

6.

 

X-Ray Machine

Use of X-rays to diagnose or treat patients by imaging the internal structure of the body to assess the abnormalities in the body.  

Class C

 

7.

Bone marrow cell separator It is a general lab equipment to be used to isolate target cells and cells concentrate from bone and blood.  

Class B

 

8.

Nebulizer It is device used to administer medications in the form of mist to inhale for respiratory disorders. Class C
 

9.

Blood Pressure Monitoring Devices It is device used to measure the diastolic and systolic blood pressures.  

Class B

 

10.

Digital Thermometer It is device used to record the body temperature. Class B
 

11.

*Glucometer It is a device used to measure the concentration of glucose in blood. Class C
 

12.

Organ Preservative Solution Solution for hypothermic flushing, storage and transport of organs and to maintain the organ vitality during transplant into human recipients.  

Class C

 

*  Glucometer will be regulated under IVD category

 

Notice

 

File No. 29/Misc/3/2018-DC(18)                                                 Date: 16.08.2018

 

In continuation to the earlier Notice vide File No: 29/Misc./3/2017-DC(292) dated 01.11.2017 and amended classification list dated 06.06.2018 regarding Classification of medical devices and in vitro diagnostic medical devices under the provisions of the Medical Devices Rules, 2017, the following Medical Devices have been added in the annexure I :

S. No. Notified Category Device name General Intended Use Risk Class
1. Surgical Dressings Suture Anchor (Spartan PEEK Suture Implant) Soft Tissue Repair C
2. Disposable Hypodermic Needles Special bevelled needles for implantable vascular access system Power – injectable safety non-coring needle is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through the port. It is manually activated during needle removal, and is designed to aid in the prevention of accidental needle-sticks. When used with ports that are indicated for power injection of contrast media into the central venous system, the needle is also indicated for power injection of contrast media. C
3. Internal Prosthetic Replacements Auditory Brainstem Implant System An auditory brain stem implant is a small device that is surgically implanted in the brain of a deaf person whose auditory nerves is lacking or damaged. The auditory nerves conduct the sound signals from the ear to the brain. The implant enables otherwise the deaf people to have a sensation of hearing. D
4. Surgical Dressings Sternal fixation Reconstructive implant Sternal Fixation System is intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion. C
5. Internal Prosthetic Replacements Dural Graft Implant Dural Graft Implant is intended for use in procedures where the repair or substitution of the patient’s dura mater is needed. C
6. Catheters Implantable infusion pumps with Catheters Intended to treat chronic pain and spasticity patients. The pump is inserted below the ribs and it designed to continually transport medication to the site of action. Doses are accurate, user friendly and the device does not restrict movement. D
7. Catheters Laser Sheath Intended for use as adjuncts to conventional lead extraction tools in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads constructed with silicone or polyurethane outer insulation C
8. Internal Prosthetic Replacements Gluteus implants Implant for augmentation of buttocks C
9. Internal Prosthetic Replacements Calf implants Implant for augmentation of Calf C
10. Blood Bags Blood bags without anticoagulant It is indicated for the collection of human blood and the preservation of blood components. C
11. Blood Bags Blood bags with anticoagulant It is indicated for the collection of human blood and the preservation of blood components. C
12. Catheters Trocars A trocar is made up of an obturator (which may be a metal or plastic sharpened or non-bladed tip), a cannula(basically a hollow tube), and a seal. The trocar functions as a portal for the subsequent placement of other instruments, such as graspers, scissors, staplers, etc. It is also intended to remove air or fluid for the pleural space in a closed, one way fashion. B
13. Catheters Ureteral stent Indicated to relieve obstructions in variety of benign, malignant and post- traumatic condition in the ureter. These conditions include stones and/or stone fragments or other Ureteral obstructions such as those associated with ureteral strictures, malignancy of abdominal organs, retroperitoneal fibrosis or ureteral trauma or in association with the Extracoporeal Shock wave lithotripsy (ESWL). The stent may be placed using endoscopic or percutaneously using standard or radiographic technique. C
14. Heart Valves Transcatheter Heart Valve It is intended for people with symptomatic aortic stenosis who are considered an intermediate or high risk patient for standard valve replacement surgery. D
15. Surgical Dressings Liquid bandage Prevention of injection by limiting exposure to dirt and germs in case of minor cuts, abrasions and blisters. B
16. Disposable Perfusion Sets Hemoconcentrator set A hemoconcentrator is a fluid removal device used during cardio bypass surgery. The device is inserted into the extracorpeal circuit where it acts to control hemodilution, maintain hematocrit levels and reduce the need for additional blood products during and after surgery. C
17. Disposable Perfusion Sets Apheresis Kit Intended for the collection and separation of blood components C
18. Disposable Perfusion Sets Blood Filter System Intended for collection and preparation of various blood components C
19. Internal Prosthetic Replacements Injectable implant for the treatment of vesicoureteral reflux Treatment of vesicoureteral reflux C
20. Surgical Dressings Bone wax/Haemostat To stop bleeding at bones in orthopaedics and traumatology, thoracic surgery, dental, oral jaw surgery, neurosurgery. C
21. Disposable Hypodermic Syringes Hyaluronic acid (cross linked) Pre-filled syringe For intradermal implantation and facial soft tissue augmentation. C
22. Disposable Hypodermic Syringes Crosslinked sodium hyaluronate It is indicated as viscoelastic supplement or a replacement for synovial fluid in human joints. It is suited for treatment of symptoms of human joint dysfunctions such as osteoarthritis. The actions of the product are lubrication and mechanical support. C
23. Disposable Hypodermic Syringes Hyaluronic acid with Lidocaine (cross linked) Pre-filled syringe It is indicated for the treatment of fine lines and medium sized skin depressions and correcting infraorbital skin depressions via deep injection C
24. Disposable Perfusion Sets Heat and moisture exchange/filter It is intended to use for airway management by anaesthesia/respiratory care department. B
25. Catheters Balloon dilators for Gastroenterology Used to dilate strictures of the gastrointestinal tract, including strictures of the esophagus, pylorus, duodenum and colon. C
26. Internal Prosthetic Replacements Hernia mesh Indicated to reinforce soft tissue where weakness exists, i.e., repair of hernias and chest wall defects. C
27. Disposable Hypodermic Needles Dental needles Dental needles are used to deliver local anaesthetic to the operative site in order to make a patient as comfortable as possible. B
28. Disposable Hypodermic Needles Spinal Needles Used for diagnostic sampling of cerebrospinal fluid, delivering anesthetics and for the introduction of contrast medium B
29. Disposable Hypodermic Syringes Ophthalmic Viscosurgical Device Viscoelastic solution for Intraocular use during eye surgery. C
30. Catheters Negative pressure wound therapy bandage Intended to generate negative pressure or suction to remove wound exudates , infection materials and tissue debris from the wound bed which may promote wound healing. C
31. Ablation Devices Needle Electrode The needle electrode family is intended to be used in conjunction with the RF generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions. C
32. Ablation Devices Radio Frequency (RF) Generator Intended for general use in electrosurgical coagulation of tissue. C
33. Surgical dressings Absorbent Cotton wool It is intended to used for applying medication to, or absorbing small amounts of body fluids A

 

Notice

 

File No. 29/Misc/3/2018-DC(85)                                                 Date: 06.06.2018

 

In continuation to the earlier Notice vide File No: 29/Misc./3/2017-DC(292) dated 01.11.2017 regarding Classification of medical devices and in vitro diagnostic medical devices under the provisions of the Medical Devices Rules, 2017, the Annexure-1 is hereby revised for the following changes:

 

  1. Deletion of S.N. 333 i.e. Sterile
  2. Revision of risk class of following products:
S.N. Product Name Earlier Risk

Classification

Revised Risk Classification
256 Intra Osseous Fixation Wire Class B Class C
259 Bone Wire Class B Class C
260 Bone Cap Class B Class C
321 Plates, Clippers,

Screws

Class B Class C

***

 

Annexure 1 (Amended as on 06.06.2018)

 

LIST OF MEDICAL DEVICES AND IN VITRO DIAGNOSTICS ALONG WITH THEIR RISK CLASS AS PER THE PROVISIONS OF RULE 4 OF THE MEDICAL DEVICES RULES 2017

 

  • List of Medical Devices under provisions of sub-rule (1) rule 4 of the Medical Devices Rules, 2017
# Notified Device
Category/Drug
  Device Name Risk Class General Intended Use
1 Ablation Device Vein Ablation Device Class C It is a non-thermal, minimally-invasive Choice for treating the source of varicose veins, providing patients with immediate recovery and a return to normal daily routines
2 Ablation Device Thermal Ablation Device Class C Destruction of tissue by application of heat. Ablation of the endometrium as a treatment for menorrhagia is performed by placing a balloon filled with hot water in the uterine cavity.
3 Ablation Device Radiofrequency Ablation Device Class D A medical procedure in which part of the electrical conduction system of the heart, tumour or other dysfunctional tissue is ablated using the heat generated from high frequency alternating current
4 Ablation Device Percutaneous Conduction Tissue Ablation Class D Clinical applications using hollow needles (cryoprobes) through which cooled, thermally conductive, fluids are circulated.
5 Ablation Device Suction Ablation Catheter System Class D Intended for use in inactivating portions of the heart’s conduction system to prevent abnormal heartbeat rates, comprises a tubular body having an open, distal end and a proximal aperture for applying suction through the catheter and through the distal end.
6 Ablation Device Uterine balloon therapy devices Class C System is a closed-cycle cryosurgical device intended to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.
7 Ablation Device RF Conducte MR steerable electrode catheter Class C It is intended for intracardiac ablation.
8 Bone Cements Bone cement Class C Intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.
9 Cardiac Stents Coronary stent Class D A coronary stent is a tube-shaped device placed in the coronary arteries that supply blood to the heart, to keep the arteries open in the treatment of coronary heart disease.
10 Cardiac Stents Bioresorbable Vascular Scaffold (BVS) System Class D An absorbable stent which is placed into a blood vessel (coronary artery) during angioplasty to help keep the coronary artery open.
11 Cardiac Stents Bifurcation Stent Class C Intended for improving the side branch luminal diameter of arterial bifurcation liaisons.
12 Catheters Fiberoptic Oximeter Catheter Class B Intended for monitoring the balance between oxygen delivery and consumption at the bedside
13 Catheters A-V Shunt or Fistula Adapter Class B A blood access device and accessories is a device intended to provide access to a patient’s blood for haemodialysis or other chronic uses.
15 Catheters Transcervical(Ami noscope)
Endoscope and accessories
Class B It is a device designed to permit direct viewing of the foetus and amniotic sac by means of an open tube introduced into the uterus through the cervix.
16 Catheters Forceps, endoscopic Class B Grasping Forceps device is intended to be used to grasp tissue, retrieve foreign bodies, and remove tissue from within the gastrointestinal tract.
17 Catheters Transabdominal (Fetoscope) Aminoscope and Accessories Class C It is a device designed to permit direct visual examination of the foetus by a telescopic system via abdominal entry. The device is used to ascertain foetal abnormalities
18 Catheters Anaesthetic Conduction Kit Class C An anaesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anaesthesia. The device may contain syringes, needles, and drugs.
19 Catheters Angiographic Guide Wire Class D It delivers radio opaque media and therapeutic agents to selected sites in the vascular system. It is also used to lead a guide wire or a catheter into the target site.
20 Catheters Cardiac Catherization Kit Class D Cardiac catheterization is a general term for a group of procedures that are performed using this method, such as coronary angiography and left ventricle angiography
21 Catheters Vena Cava Filter Sets Class C It is indicated for the prevention of recurrent pulmonary embolism via placement in the vena cava to treat various disease conditions.
22 Catheters Vessel Dialator for percutaneous Catheterization Class B A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.
23 Catheters Tracheobronchial Suction Catheter Class B Clearing the airways of mucus, pus, or aspirated materials to improve oxygenation and ventilation.
24 Catheters Cervical Drain Class B The device is used to avoid postoperative wound and respiratory complications such as excessive edema, hematoma, infection, re- intubation, delayed extubation, or respiratory distress
25 Catheters Rectal Balloon Class B Reducing the intrafraction motion and improving the sparing of rectal wall by reducing the rectal volume in the high- dose region, resulting in significant reduction in rectal toxicity.
26 Catheters Balloon for Cerebrovascular Occlusion Class D Balloon used to treat Blockage or closing of Cerebrovascular vessels/carotid arteries
27 Catheters Intra-Aortic System Balloon and Control Class D It is a mechanical device that increases myocardial oxygen perfusion while at the same time increasing cardiac output
28 Catheters Biliary Stone Retrieval Basket Class B Intend to extract stones in an antegrade fashion through an ampullary orifice previously treated by endoscopic sphincterotomy or less commonly with balloon dilation
29 Catheters Tracheostomy Tube/Tracheal Tube Class B A breathing tube inserted into a tracheotomyused to obtain a closed circuit for ventilation
30 Catheters Vial Adapter Class B It is indicated to allow multiple needleless access to injection medication vials for transfer or withdrawal of fluids from the vial.
31 Catheters Suprapubic, non- disposable Cannula Class B An emergency measure for the relief of acute urinary retention or condition which require temporary and permanent drainage of bladder.
32 Catheters Nasopharyngeal Catheter/Nasophar yngeal Class A A catheter (for adults) passed through the nares and advanced to the depth of the nasopharynx to remove air choke or obstruction. AResuscitator.
33 Catheters Esophageal obturator Class B Inserted through a patient’s mouth to aid ventilation of the patient during emergency resuscitation by occluding (blocking) the esophagus, thereby permitting positive pressure ventilation through the trachea.
34 Catheters Balloon Catheter for Retinal Reattachment Class B An instrument for reattachment of a detached retina to the inner wall of the eyeball. It can be inserted into the interior of the eyeball.
35 Catheters Gastric, Colonic, etc.) Irrigation and Aspiration Catheter Class B Used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract.
36 Catheters Suction Tip and Catheter Class B Suction Catheters feature a whistle tip and a thumb control port for precise and accurate suctioning.
37 Catheters Angiographic Catheter Class B Designed to provide a pathway for delivering contrast media to selected sites in the device vascular system including the carotid arteries.
38 Catheters Arterial Catheter Class B Intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature.
39 Catheters Balloon Type Catheter Class B “Soft” catheter with an inflatable “balloon” at its tip which is used during a catheterization procedure to enlarge a narrow opening or passage within the body.
40 Catheters Balloon Dialation Vessel Catheter Class B Intended for use in Percutaneous Transluminal Angioplasty of the renal, tibial, popliteal, femoral and peroneal arteries. These catheters are not for use in coronary arteries.
41 Catheters Bartholin Gland Catheter Class B Catheter is used for the treatmenti of abscesses and cysts of the Hartholin gland.
42 Catheters Bronchography Catheter Class B Intended to deliver therapeutic and diagnostic agents that are indicated or labeled for airway, tracheal or
43 Catheters Cholangiography Catheter Class B Diagnostic evaluation of the bile ducts during laparoscopic cholecystectomy procedures
44 Catheters Anesthetic Conduction Catheter Class B An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia
45 Catheters Anesthesia conduction filter Class C A microporous filter used while administering to a patient injections of local anesthetics to minimize particulate (foreign material) contamination of the injected fluid
46 Catheters Continuous Flush Catheter Class B Intended for the controlled and selective infusion of
47 Catheters Continuous Irrigation Catheter Class B Intended to be used to introduce fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.
48 Catheters Coude Catheters Class B It is a urinary catheter, It may be used to inject liquids used for treatment or diagnosis of bladder conditions.
49 Catheters Depezzer Catheter Class B A tubular, flexible instrument, passed through body channels for withdrawal o f fluids from a body cavity.
50 Catheters Double lumen Female Urethrographic Catheter Class B Intended for vascular access infusion and withdrawal of blood, blood products, and fluids, plasma pheresis, hyperalimentation, central venous blood sampling and continuous and intermittent drag infusion.
51 Catheters Epidural Catheter Class B Epidural catheter is a very thin, flexible tube that is implanted into spine
52 Catheters Esophageal Balloon Catheter Class B intended for use in adult and adolescent populations
53 Catheters Eustachian Catheter Class B It is used to test Eustachian tube patency
54 Catheters Guiding Catheter Class B The guide catheter provides support for device advancement .
55 Catheters Haemodialysis Catheter Class B A catheter used for exchanging blood to and from the haemodialysis machine from the patient.
56 Catheters Central Venous Catheters Class C It is indicated for use in patients requiring administration of solutions, blood sampling, central venous pressure monitoring and injection of contrast media.
57 Catheters Intramuscular Pressure Monitoring Catheter Class B A modified fibre optic transducer- tipped catheter system for measuring intramuscular pressures during exercise was determined.
58 Catheters Introducer Sheath Class C Intended to provide easier access to the femoral, popliteal and infrapopliteal arteries.
59 Catheters Intravenous Catheter Class B A catheter that is inserted into a vein for supplying medications or nutrients dir ectly into the bloodstream or for diagno sticpurposes such as studying blood pressure
60 Catheters Jejunostomy Catheter Class B Used for intraoperative feeding jejunostomy
61 Catheters Multiple Lumen Catheter Class B Intended for monitoring central venous pressure (CVP), sampling blood, and simultaneou administratio of multiple IV solutions or drugs
62 Catheters Nasal Oxygen Catheter Class B It is a device used to deliver supplemental oxygen or increased airflow to a patient or person in need of respiratory help.
63 Catheters Embolic Filter system Class D It is indicated for general use as a guidewire and embolic protection system during angioplasty and stenting procedures in carotid arteries with reference vessel diameters of 2.5 to 5.5mm.
64 Catheters Carotid Filter System Class C Used while performing angioplasty and stenting procedures in carotid arteries.
65 Catheters RETRIEVAL SNARE Class C intended for use in the retrieval and manipulation of atraumatic foreign bodies located in the coronary and peripheral cardiovascular system and the extra- cranial neurovascular anatomy.
66 Catheters RETRIEVAL SNARE Class D intended for use in the retrieval and manipulation of atraumatic foreign bodies located in the coronary and peripheral system and the extra cranial neurovascular anatomy.
67 Catheters Nephrostomy Catheter Class B A nephrostomy is a tube that’s used to drain urine from a kidney into a bag outside the body.
68 Catheters Peritoneal Dialysis Catheter Class B That allows dialysis fluid to enter the abdominal cavity, dwell inside for a while, and then drain back out again
69 Catheters Radiographic (Non Vascular) Catheter Class B Interventional radiologists obtain images using needles and narrow tubes called catheters, rather than by making large incisions into the body as in traditional surgery.
70 Catheters Rectal Catheter Class B It is inserted into the rectum in order to relieve flatulence which has been chronic and which has not been alleviated by other methods.
71 Catheters Retention Type Catheter Class B This type of catheter is placed into the bladder and secured there for a period of time.
72 Catheters Retention Type Balloon Catheter Class B It has a balloon at the distal end, which is inflated with sterile water or saline to prevent the catheter from slipping out of the bladder
73 Catheters Salpngography Catheter Class B Used for injection of contrast medium
into the fallopian tube(s) for selective salpingography.
74 Catheters Single Needle Hemodialysis Catheter/Blood lines Class B The single-needle dialysis, in which case only one cannula or a single- lumen catheter is used to access the blood
75 Catheters Straight Catheter Class B It is used in patients with neurogenic bladder or spinal cord injury, lessens the risk of urinary tract infection
76 Catheters Subclavian Catheter Class B Catheters can be placed in veins in the neck (internal jugular vein), chest (subclavian vein or auxiliary vein),
77 Catheters Suprapubic Catheter Class B A suprapubic catheter is a thin, sterile tube used to drain urine from bladder.
78 Catheters Umblical Artery Catheter Class B Umbilical artery catheterization provides direct access to the arterial blood supply and allows accurate measurement of arterial blood pressure, a source of arterial blood sampling, and intravascular access for fluids and medications
79 Catheters Upper Urinary Tract Catheter Class B The catheter to the bladder and subsequently to the upper urinary tract
80 Catheters Urethral Catheter/Nelaton Catheter/ Foley Catheter Class B A long, small gauge catheter designed f or insertion directly into a ureter, either through the urethra andbladder or post eriorly via the kidney.
81 Catheters Urethrographic Male Catheter Class B A catheter used to pass into a man’s bladder.
82 Catheters Chorionic Villus Sampling Catheter Class B An ultrasound guides a thin catheter through the cervix to your placenta. The chorionic villi cells are gently suctioned into the catheter.
83 Catheters Sclerotherapy Needle/ Catheter Class B Sclerotherapy Needles are designed to provide access for injection therapy applications and may also be used for polypectomy and endoscopic mucosal resection (EMR)
84 Catheters Water Jet Renal Catheter Class B A device used to dislodge stones from renal calyces (recesses of the pelvis of the kidney) by means of a pressurized stream of water through a conduit.
85 Catheters Hemodialysis Catheter (Long Term ) Class C A dialysis catheter is a catheter used for exchanging blood to and from the hemodialysis machine from the patient. The dialysis catheter contains two lumens: Venous. Arterial
86 Catheters Percuataneous Intravascular Long Term Catheter Class C The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood;
87 Catheters Percutaneous Long Term Intraspinal Catheter Class C To conduct a preimplantintra spinal infusion screening trial procedure prior to implanting a pump
88 Catheters Implanted Subcutaneous Intravascular Port & Catheter Class C The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood
89 Catheters Subcutaneous Intraspinal Port & Catheter Class C Catheters used for both epidural Intrathecal infusion include short-term externalized catheters and long-term catheters that are tunnelled in the subcutaneous tissue
90 Catheters Peripheral, Transluminal Angioplasty Catheter Class C A catheter for treating peripheral vascular diseases
91 Catheters Cardiac Thermodilution Catheter Class D A catheter used in thermodilution for in troduction of the cold liquid indicator into thecardiovascular system or for the assessment of a patient’s hemodynamic condition through simultaneous right atrial, right ventricular, and pulmonary artery or wedge pressure monitoring, cardiac output determination, and for infusing solutions.
92 Catheters Cardiovascular Catheter Class D A thin, hollow tube called a catheter is inserted into a large blood vessel that leads to heart.
93 Catheters Cerebrospinal Catheter Class D For treatment or prevention of cranial/spinal cerebrospinal fluid fistula.
94 Catheters Atherectomy Coronary Catheter Class D A catheter containing a rotating cutter and a collecting chamber for debris, used for atherectomy and endarterectomy.
95 Catheters Electrode Recording Probe, Electrode Recording Catheter Class D A cardiac catheter containing one or more electrodes; it may be used to pace the heart or to deliver high energy shocks.
96 Catheters Oximetry catheters, Oximetry Paceport catheter Class B It is indicated for the assessment of a patient’s hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, continuous mixed venous oxygen saturation monitoring, and for infusing solutions
97 Catheters Embolectomy Catheter Class D indicated for the removal of fresh, soft emboli and
98 Catheters Flow Directed Catheter Class B Used for venous sampling and pressure monitoring.
99 Catheters Ultrasonic maging Catheter Class D intended for ultrasound examination of peripheral pathology only
100 Catheters Intraaortic Balloon Catheter Class D It is indicated for use in patients undergoing cardiopulmonary bypass.
101 Catheters Intracardiac Mapping, High Density Array Catheter Class D A high density array catheter once used in the right atrium to map and diagnosis complexarrhythmias and assess the effe ctiveness of ablation treatment.
102 Catheters Coronary Dilation Catheter Class C It is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.
103 Catheters Intravascular Occluding Catheter Class D It is a catheter with an inflatable or detachable balloon tip that is used to block a blood vessel to treat malformations, e.g., aneurysms of intracranial blood vessels
104 Catheters Intravascular Diagnostic Catheter Class D Used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels.
105 Catheters Occlusion Catheter Class D Insertion of a device or develop at any time during the course of intravenous (IV) therapy.
106 Catheters Percutaneous Catheter Class D A needle catheter getting access to a blood vessel, followed by the introduction of a wire through the lumen (pathway) of the needle.
107 Catheters Diagnostic Radiology Catheters Class C Angiography catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.
108 Catheters Perfusion Catheter Class D Perfusion catheter allowing localised perfusion of drugs not only into the vessel lumen, but also directly into the vessel wall at low pressure, during coronary intervention. –
109 Catheters Pericardium Drainage Catheter Class D Catheter drainage of the pericardium
110 Catheters Atherectomy Peripheral Catheter
Class D
Intended for use in atherectomy of the peripheral vasculature.
111 Catheters Septostomy Catheter Class D Used to enlarge interatrial openings
112 Catheters Thrombectomy Catheter Class D Thrombectomy catheter is specifically designed to treat deep vein thrombosis (DVT) in large-diameter upper and lower peripheral veins.
113 Catheters Transluminal, Coronary Angioplasty, Percutaneous Catheter Class D The catheter is placed in the opening or ostium of one the coronary arteries
114 Catheters Ventrricular Catheter Class C It is used to monitor pressure in patients with brain injuries, intracranial bleeds or other brain abnormalities that lead to increased fluid build-up.
115 Catheters Balloon Repair Kit Catheter Class C A device used to repair or replace the balloon of a balloon catheter. The kit contains the materials, such as glue and balloons, necessary to affect the repair or replacement.
116 Catheters Micro-catheter Class C It is intended to access the peripheral and neurovasculature for the controlled selective infusion of physician- specified therapeutic agents such as embolization materials and or diagnostic materials such as contrast media
117 Catheters Imaging Catheter Class C Intended for use with the various medical imaging consoles.
118 Catheters Central Nervous System Shunt including Neurological catheters and other Components Class D It is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume.
119 Catheters Endoscopic Ligation Devices Class B It is used for proximal and distal ligation of vessels during endoscopic vessel harvesting procedures.
120 Catheters Dialysate Tubing and Connector Class B A tubing connector adapted for peritoneal dialysis connections between tubing sets and containers of dialysate
121
Catheters
Urinary Drainage Unit Class B A closed urinary drainage system consists of a catheter inserted into the urinary bladder and connected via tubing to a drainage bag
122 Catheters Tympanostomy Tube Class C It is a small tube inserted into the eardrum in order to keep the middle ear aerated for a prolonged period of time, and to prevent the accumulation of fluid in the middle ear
123 Catheters In-Vitro Fertilization/Embryo Transfer Catheter Class B A cellular transfer catheter is provided for implantation of cellular material into the uterus of a patient
124 Catheters Sclerotherapy Needle/ Catheter Class B It is designed to provide access for injection therapy applications and may also be used for polypectomy and endoscopic
125 Catheters Fluid Delivery tubing Class B Tube used to deliver fluid in body
126 Catheters Colon Tube Class B Colon Tubes also called “Tips” or even Catheters are inserted from the anus, through the rectum to deliver your enema solution into the colon (large intestine).
127 Catheters Connecting Tube Class B Used to provide connection to a drainage bag.
128 Catheters Decompression Tube Class B Decompression using a rectal tube may assist in the treatment only if the sigmoid colon is involved.
129 Catheters Double Lumen for intestinal Decompression and/or Intubation Tube Class B Tracheal intubation, usually simply referred to as intubation, is the placement of a flexible plastic tube into the trachea (windpipe) to maintain an open airway or to serve as a conduit through which to administer certain drugs.
130 Catheters Closed Wound Drainage Tube or System Class B A surgical drain is a tube used to remove pus, blood or other fluids from a wound. They are commonly placed by surgeons or interventional radiologists.
131 Catheters Oesophageal Blakemore Tube Class B It is a medical device inserted through the nose or mouth and used occasionally in the management of upper gastrointestinal hemorrhage due to oesophageal varices .
132 Catheters Oesophageal Sengtaken Tube Class B It is used only in emergencies where bleeding from presumed varices is impossible to control with medication alone
133 Catheters Feeding Tube Class B A feeding tube is a device that’s inserted into your stomach through your abdomen. It’s used to supply nutrition when you have trouble eating
134 Catheters Gastro- Enterostomy Tube Class B Tube is placed through the abdominal wall into the stomach and then through the duodenum into the jejunum.
135 Catheters Gastrointestinal Tube Class B A gastrostomy tube (also called a G- tube) is a tube inserted through the abdomen that delivers nutrition directly to the stomach
136 Catheters Heart-Lung Bypass Unit Tube Class B A tube will be placed in your heart to drain blood to the machine.
137 Catheters Levine Tube Class B Used for the aspiration of gastric and intestinal contents and administration of tube feedings or medications.
138 Catheters NasoGastric Tube/ Ryles Tube Class B It is a special tube that carries food and medicine to the stomach through the nose. It can be used for all feedings or for giving a person extra calories.
139 Catheters Nephrostomy Tube Class B The nephrostomy tube drains urine from kidney into a collecting bag outside the body.
140 Catheters Orthodontic Tube Class B An orthodontic small metal part welded on the outside of a molar bank, which contains slots to holdarchwires, lip bu mpers, facebows and other devices use d to move the teeth.
141 Catheters Rectal Tube Class B A rectal tube, also called a rectal catheter, is a long slender tube which is inserted into the rectum in order to relieve flatulence .
142 Catheters Stomach Evaculator(Gastric Lavage) Tube Class B Passage of a tube via the mouth or nose down into the stomach followed by sequential administration and removal of small volumes of liquid.
143 Catheters Tonsil Suction Tube Class B Used to suck out stones in tonsils.
144 Catheters Tracheal (Endotracheal) Tube Class B Inserts the tube with the help of a laryngoscope, an instrument that permits to see the upper portion of the trachea, just below the vocal cords.
145 Catheters Closed Suction System Class B It is intended for endotracheal suctioning to provide a patient airway by removing excess fluids, secretions, exudates and transudate through the artificial airway.
146 Catheters Anastomosis Bypass Tube Class C It is anchored to mucosa and submucosa 3 centimetres proximal to a site of colocolonic anastomosis and later spontaneously evacuated by way of the rectum.
147 Catheters Endolymphatic Shunt Tube Class B During a surgical procedure in which it is placed in the membranous labyrinth of the inner ear to drain excess fluid.
148 Catheters Orthodontic Guide Wire Class B A wire conforming to the alveolar or dental arch that can be used with dental braces as a source of force in correcting irregularities in the position of the teeth
149 Catheters Intra-aortic balloon and control system Class D It is a medical device which is placed in the aorta to improve cardiovascular functioningduringcertain life- threatening emergencies.
150 Catheters Ventricular bypass (assistive) Class D A ventricular bypass (assistive) device is a device that assists the left or right ventricle in maintaining circulatory blood flow.
151 Catheters Catheter Guide Wire Class D It is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The PTCA Guide Wires are not to be used in the cerebral blood vessel
152 Catheters Catheter Guide Class D It is intended to facilitate the placement of balloon ilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). PTCA Guide Wires are not to be used in the cerebral blood vessel.
153 Catheters Wire Class C An esophageal stent is a stent (tube) placed in the oesophagus to keep a blocked area open so the patient can swallow soft food and liquids
154 Catheters Biliary stents Class C Biliary stents provide bile drainage from the gallbladder, pancreas and bile ducts to the duodenum in conditions such as ascending cholangitis due to obstructing gallstones
155 Catheters Duodenal stents Class C Duodenal Stent is indicated for the palliative treatment of gastroduodenal obstructions
156 Catheters Colonic stent Class C A colonic stent is a flexible, hollow tube designed to keep a segment of the colon (large bowel) open when it has become blocked(obstructed). This blockage is commonly caused by a tumour inside the bowel or by outside pressure on the bowel wall.
157 Catheters Pancreatic stent Class C Pancreatic duct stents are often placed in patients who have chronic pancreatitis
158 Catheters Carotid Stent System Class D Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization.
159 Catheters Peripheral Stent System Class C A Peripheral stent is a tube-shaped device placed in the peripheralarteries that supply blood into body organ.
160 Contraceptives Tubal Rings/ Fallopian Rings Class C Contraception devices for female sterilization
161 Contraceptives Male / Female Condoms Class C Condom with nonoxynol-9, micro condom, prophylactic (condom) – latex sheath, non-latex, condoms with natural membrane, intra vaginal condoms etc.
162 Contraceptives Cu-T Class D Indicated for intrauterine contraception for up to 10 years.
163 Disinfectants Disinfectants Class B An agent that destroys pathogenic and other kinds of microorganisms by chemical or physical means. A disinfectant destroys most recognized pathogenic microorganisms, but not necessarily all microbial forms, such as bacterial spores. It is intended to disinfect a medical device.
164 Disposable Hypodermic Neeldes Aspiration Needle Class B Used for either laparoscopic aspiration or injection
165 Disposable Hypodermic Neeldes Aspiration and Injection Needle Class B A thin needle is inserted into an area of abnormal-appearing tissue or body fluid. As with other types of biopsies, the sample collected during fine needle aspiration can help make a diagnosis or rule out conditions such as cancer.
166 Disposable Hypodermic Neeldes Insulin Needles/Pen Class B Used to inject insulin for the treatment of diabetes.
167 Disposable Hypodermic Neeldes Needles for insulin Medication Injector Class B A subcutaneous injection is a method of administering medication.
168 Disposable Hypodermic Neeldes Biopsy Needle Kit Class B A set of neurosurgical instruments designed to allow multiple biopsies from one or more targets in one trajectory
169 Disposable Hypodermic Neeldes Angiographic Needle Class B Angiographic needle has a unique hub design with an ergonomic feel and a black triangle indicator to orient the bevel.
170 Disposable Hypodermic Neeldes Mammary Biopsy Needle Class B The growth sample is suctioned out through a needle or cut out using a surgical procedure
171 Disposable Hypodermic Neeldes Blood Collecting Needle Class B Intended to be used with evacuated blood collection tube for collection of venous blood.
172 Disposable Hypodermic Neeldes Bone Marrow Needle Class B Needle inserted in Bone Marrow to collect sample
173 Disposable Hypodermic Neeldes Gynaecological Cerclage Needle Class B It is a loop like instrument used to suture the cervix.
174 Disposable Hypodermic Neeldes Cholangiography Needle Class B The aspirating needle is passed through the patient’s skin and liver tissue until the tippenetrates one of the hepatic ducts
175 Disposable Hypodermic Neeldes Anaesthetic Conduction Needle Class B An anaesthesia conduction needle is a device used to inject local anaesthetics into a patient to provide regional anaesthesia
176 Disposable Hypodermic Neeldes Emergency Airway Needle Class B Emergency airway puncture is the placement of a hollow needle through the throat into the airway. It is done to treat life-threatening choking.
177 Disposable Hypodermic Neeldes Endoscopic Needle Class B Used to sample targeted submucosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope.
178 Disposable Hypodermic Neeldes Fistula Needle Class B To connect blood lines with the blood vessels through needles when dialysis is carried out
179 Disposable Hypodermic Neeldes Epidural Needle Class B Intended for transient delivery of anasthetics to provide regional anesthesia or to facilitate placement of an epidural catheter
180 Disposable Hypodermic Neeldes Gastro-Urology Needle Class B Intended for gastroenterology biopsy
181 Disposable Hypodermic Neeldes Single Lumen Hypodermic Needle Class B A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
182 Disposable Hypodermic Neeldes Neurosurgical Suture Needle Class B A needle used in suturing during neurosurgical procedures or in the repair of nervous tissue.
183 Disposable Hypodermic Neeldes Oocyte Aspiration Needle Class B Mission to collect the maximum amount of undamaged oocytes in a short time as possible.
184 Disposable Hypodermic Neeldes Pneumoperitoneu m Simple Needle Class B Inserting a Veress needle through the abdominal wall inside the peritoneal cavity.
185 Disposable Hypodermic Neeldes Prefillable Glass Barrel with needle Class B Intended for the automatic self- administration of drugs and biologics from standard Glass Barrel.
186 Disposable Hypodermic Syringes Injector Type actuator syringe Class C A syringe actuator for an injector is an electrical device that controls the timing of an injection by an angiographic or indicator injector and synchronizes the injection with the electrocardiograph signal.
187 Disposable Hypodermic Syringes Aspiration Syringe Class B Used for either laparoscopic aspiration or injection
188 Disposable Hypodermic Syringes Irrigating Syringes Class B cleaning debris away from the area the dentist is working on
189 Disposable Hypodermic Syringes Insulin Syringes Class B Used to inject insulin for the treatment of diabetes.
190 Disposable Hypodermic Syringes Auto Disable Syringe for single use Class B Intend to inject fluids into or withdraw fluids from the body.
191 Disposable Hypodermic Syringes Traditional    single use syringe without safety feature (Sterile hypodermic syringes for single use) Class B Intend to inject fluids into or withdraw fluids from the body.
192 Disposable Hypodermic Syringes Auto-disable (AD) syringes for immunization Class B Intend to inject fluids into or withdraw fluids from the body.
193 Disposable Hypodermic Syringes Re use Prevention (RUP) syringes for therapeutic injections Class B Intend to inject fluids into or withdraw fluids from the body.
194 Disposable Perfusion Sets (Syringes with re-use prevention feature) Sharps Injury Protection (SIP) – Plastic needle shield to be added to a syringe Class B Intend to inject fluids into or withdraw fluids from the body.
195 Disposable Perfusion Sets Sharps Injury Blood Administration kits Class B It is used to administer blood from a container to a patient’s vascular system through a needle or catheter inserted into a vein.
196 Disposable Perfusion Sets Measured     Volume IV Set Class B It is intended for use in the administration of fluids from a container into the patient’s vascular system through a vascular access device.
197 Disposable Perfusion Sets Transfusion or Perfusion sets for single use Class B Transfusion Set is used to administer blood/drugs to a patient’s vascular system through a needle or catheter inserted into a vein.
198 Disposable Perfusion Sets Custom Perfusion System Class C Indicated for use in the extra corporeal circuit during cardio pulmonary bypass surgery procedure.
199 Disposable Perfusion Sets Manifolds Class B Indicated for fluid flow directional control and for providing access port/ports for administration of a solution.
200 Disposable Perfusion Sets 3 way stop cock as an accessory to perfusion sets Class B It is indicated for fluid flow directional control and for providing access port for administration of solution, withdrawal of fluid and pressure monitoring
201 Disposable Perfusion Sets Y-Connector as an accessory to perfusion sets Class A It can be used to connect to a perfusion sets or catheter for infusion of contrast media etc.
202 Disposable Perfusion Sets I V Flow regulator Class B An IV system and administration device offering precision care and consistent delivery.
203 Disposable Perfusion Sets Extension Sets Class B Extension sets are sterile devices for single use only. They are intended to be used as part of a system for the infusion of fluids/medications in medical applications.
204 Disposable Perfusion Sets Infusion Pump or Elastomeric Infusion Device Class C The Infusion Pumps intended for slow, continuous delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), and subcutaneous or epidural infusion of medications directly into an intra-operative site or subcutaneously
for post operative pain management.
205 Drug Eluting Stents Drug eluting stent Class D Stent, coronary, drug-eluting – a metal scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis.
206 Heart Valves Heart valve Class D A device intended to perform the function of any of the heart’s natural valves.
207 Internal Prosthetic Replacements Tissue Expanders Class C Intended to be used in breast reconstruction or treatment of soft tissue deformities such as used following mastectomy or for treatment of underdeveloped breasts.
208 Internal Prosthetic Replacements Bio Patches Class C Intended for reconstruction and repair of defects of pericardium.
209 Internal Prosthetic Replacements Vascular graft/occluders/Car diac Patches Class D Intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.
210 Internal Prosthetic Replacements Vascular embolization device Class D It is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors.
211 Internal Prosthetic Replacements Voice / laryngeal Prothesis Class C The device is intended to direct pulmonary air flow to the pharynx in the absence of the larynx, for permitting esophageal speech.
212 Internal Prosthetic Replacements Cardiovascular prosthetic devices Class D An intra-cardiac patch or pledgete which is a medical device placed in the heart and is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.
213 Internal Prosthetic Replacements Hearing Prosthesis System Class C The prostheses are intended for partial ossicular replacement to restore functionality to the middle ear .
214 Internal Prosthetic Replacements Annuloplasty ring Class C An annuloplasty ring implanted around the mitral or tricuspid heart valve for reconstructive treatment.
215 Internal Prosthetic Replacements Total ossicular replacement prosthesis Class D It is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear.
216 Internal Prosthetic Replacements Ear, nose, and throat and facial synthetic polymer material or implant Class C It is a device material that is intended to be implanted for use as a space- occupying substance in the reconstructive surgery of the head and neck.
217 Internal Prosthetic Replacements Mandibular implant facial prosthesis Class C Intended to be implanted for use in the functional reconstruction of mandibular deficits.
218 Internal Prosthetic Replacements Sacculotomy tack (Cody tack) Class C Intended to be implanted to relieve the symptoms of vertigo.
219 Internal Prosthetic Replacements Endolymphatic shunt Class C Intended to be implanted to relieve the symptoms of vertigo.
220 Internal Prosthetic Replacements An endolymphatic shunt tube with valve Class C It is a device that consists of a pressure-limiting valve associated with a tube intended to be implanted in the inner ear to relieve symptoms of vertigo and hearing loss.
221 Internal Prosthetic Replacements Fallopian tube prosthesis Class C A device designed to maintain the patency (openness) of the fallopian tube and is used after reconstructive surgery.
222 Internal Prosthetic Replacements Vaginal stent Class C A device used to enlarge the vagina by stretching, or to support the vagina and to hold a skin graft after reconstructive surgery.
223 Internal Prosthetic Replacements Eye sphere implant Class D An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.
224 Internal Prosthetic Replacements Keratoprosthesis Class D It is a device intended to provide a transparent optical pathway through an opacified cornea, either intraoperatively or permanently, in an eye.
225 Internal Prosthetic Replacements Bone heterograft Class D Intended to be implanted that is made from bovine bones and used to replace human bone following surgery in the cervical region of the spinal column.
226 Internal Prosthetic Replacements Intramedullary fixation rod Class C Intended to be implanted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
227 Internal Prosthetic Replacements Endosseous dental implant Class C Intended to be surgically placed in the bone of jaw arches to provide support for prosthetic devices, such as artificial teeth.
228 Internal Prosthetic Replacements Dental implant Class C A dental implant is a surgical component that interfaces with the bone of the jaw or skull to support a dental prosthesis such as crown, bridge, denture, facial prosthesis or to act as an orthodontic anchor.
229 Internal Prosthetic Replacements Bone grafting material Class C Intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.
230 Internal Prosthetic Replacements Total temporomandibula r joint prosthesis Class D Intended to be implanted in the human jaw to replace the mandibular condyle and augment the glenoid fossa to functionally reconstruct the temporomandibular joint.
231 Internal Prosthetic Replacements Glenoid fossa prosthesis Class D Intended to be implanted in the temporomandibular joint to augment a glenoid fossa or to provide an articulation surface for the head of a mandibular condyle.
232 Internal Prosthetic Replacements Mandibular condyle prosthesis Class D Intended to be implanted in the human jaw to replace the mandibular condyle and to articulate within a glenoid fossa.
233 Internal Prosthetic Replacements An interarticular disc prosthesis Class D Intended to be an interface between the natural articulating surface of the mandibular condyle and glenoid fossa.
234 Internal Prosthetic Replacements Penile inflatable implant Class D A penile inflatable implant is a device which is implanted in the penis, connected to a reservoir filled with radiopaque fluid implanted in the abdomen, and a subcutaneous manual pump implanted in the scrotum. This device is used in the treatment of erectile impotence.
235 Internal Prosthetic Replacements Penile rigidity implant Class C A device that is implanted in the corpora cavernosa of the penis to provide rigidity. It is intended to be used in men diagnosed as having erectile dysfunction
236 Internal Prosthetic Replacements Artificial Urinary Sphincters implants Class C It is used to prevent incontinence by occluding the urethra.
237 Internal Prosthetic Replacements Implanted mechanical/hydrau lic urinary continence device Class C An implanted mechanical/hydraulic urinary continence device is a device used to treat urinary incontinence by the application of continuous or intermittent pressure to occlude the urethra.
238 Internal Prosthetic Replacements Cochlear implant Class D A cochlear implant is an implanted electronic hearing device, designed to produce useful hearing sensations to a person with severe to profound nerve deafness by electrically stimulating nerves inside the inner ear.
239 Internal Prosthetic Replacements Retinal implant Class D The retinal implant is meant to partially restore useful vision to people who have lost their vision due to degenerative eye conditions
240 Internal Prosthetic Replacements Breast implant Class C Breast implant is used to increase the breast size.
241 Internal Prosthetic Replacements Tracheal prosthesi Class C It is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree
242 Internal Prosthetic Replacements Polymeric Surgical Mesh Class C The polymeric mesh comprises an absorbable polymeric fibre and a non- absorbable polymeric fibre knitted together to form an interdependent, co-knit mesh structure
243 Internal Prosthetic Replacements Endosseous Class C Intended for use as an aid in prosthetic rehabilitation.
244 Internal Prosthetic Replacements A testicular prosthesis Class D A testicular prosthesis is an implanted device that consists of a solid or gel-filled silicone rubber prosthesis that is implanted surgically to resemble a testicle.
245 Internal Prosthetic Replacements Aneurysm Implant (detachable coils/clips) Class D It is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
246 Intra Ocular Lenses Intraocular lens Class C Intraocular lens (IOL) are lens implanted in the eye used to treat cataracts or myopia
247 IV Cannulae Intravenous Cannula Class B The IV Cannula is a passive device to provide for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of Vascular Access devices .
248 IV Cannulae Arterial Cannula Class B Inserted into an artery, commonly the radial artery, and is used during major operations and in critical care areas to measure beat-to-beat blood pressure and to draw repeated blood samples.
249 IV Cannulae Coronary Artery Cannula Class B Cannulation technique for left-sided coronary artery surgery.
250 IV Cannulae Hemodialysis Cannula Class B Allowing the arterial blood to flow to the dialyzer and the dialyzed blood to return from the dialyzer to the circulation through the cannula in the vein.
251 IV Cannulae Vena Cava Cannula Class B Inserted into Vena Cava, taking deoxygenated blood to heart.
252 IV Cannulae Venous Cannula Class B It is intended for use as a single cannula for both venous drainage and reinfusion of blood via an internal jugular vein during extracorporeal life support procedures.
253 IV Cannulae Ventricular Cannula Class B For use in neurosurgical procedures. It is specially designed to penetrate delicate brain tissue and give continued access to brain’s ventricular system.
254 IV Cannulae A-V Shunt Cannula Class C It is inserted into one of the client’s blood vessels to facilitator repeated hemodialysis.
255 IV Cannulae Cannulact or Lymph Duct Class B A lymph duct is a great lymphatic vessel that empties lymph into one of the subclavian veins
256 Orthopaedic Implants Intra Osseous Fixation Wire Class C Stabilization of fractured bony parts by direct fixation to one another with surgical wires
257 Orthopaedic Implants Cortical  Fixation Implant / rigidloop Adjustable Cortical Fixation System Class C Cortical Fixation System is a machined titanium implant designed to provide fixation in the repair of tendons and ligaments.
258 Orthopaedic Implants Intervertebral Body Fusion Device / Fuse Spinal System Class C It is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (“DDD”) at one or two contiguous spinal levels.
259 Orthopaedic Implants Bone Wire Class C Intended to be used for bone stabilization in the hand and wrist.
260 Orthopaedic Implants Bone cap Class C Intended to be implanted to cover the end of a bone.
261 Orthopaedic Implants Orthopedic implant & accessories Class C Intended to replace a missing joint or bone or to support a damaged bone.
262 Orthopaedic Implants Intervertebral body fusion device Class D The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion
263 Orthopaedic Implants Pedicle screw spinal system Class C It is used to intended to provide immobilization and stabilization of spinal segments
264 Orthopaedic Implants Ankle joint metal/composite semi-constrained
cemented
prosthesis
Class C An ankle joint metal/composite semi- constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint.
265 Orthopaedic Implants Ankle joint metal/polymer non-constrained cemented prosthesis Class C A device intended to be implanted to replace an ankle joint. The device limits minimally translation in one or more planes. It has no linkage across- the-joint.
266 Orthopaedic Implants Elbow joint metal/polymer constrained cemented prosthesis Class C An elbow joint metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint.
267 Orthopaedic Implants Elbow joint metal/polymer semi-constrained cemented prosthesis Class C An elbow joint metal/polymer semi- constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint
268 Orthopaedic Implants elbow joint radial (hemi-elbow) polymer Class C An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.
269 Orthopaedic Implants Elbow joint humeral (hemi- elbow) metallic uncemented prosthesis Class C A device intended to be implanted made of alloys, such as cobalt- chromium-molybdenum, that is used to replace the distal end of the humerus formed by the trochlea humeri and the capitulumhumeri
270 Orthopaedic Implants elbow joint humeral (hemi- elbow) metallic uncemented prosthesis
Class C
A device intended to be implanted made of alloys, such as cobalt- chromium-molybdenum, that is used to replace the distal end of the humerus formed by the trochlea humeri and the capitulumhumeri
271 Orthopaedic Implants Finger joint metal/metal constrained uncemented prosthesis Class C A device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint
272 Orthopaedic Implants Finger joint metal/metal constrained cemented prosthesis Class C A finger joint metal/metal constrained cemented prosthesis is a device intended to be implanted to replace a metacarpophalangeal (finger) joint
273 Orthopaedic Implants Finger joint polymer constrained prosthesis Class C A device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint
274 Orthopaedic Implants hip joint metal constrained cemented or uncemented prosthesis Class D A hip joint metal constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint
275 Orthopaedic Implants Hip joint metal/polymer constrained cemented or uncemented prosthesis Class D A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint
276 Orthopaedic Implants Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis. Class D It is a prosthesis intended to be implanted to replace a hip joint
277 Orthopaedic Implants hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Class D Intended to be implanted to replace a hip joint
278 Orthopaedic Implants hip joint metal/composite semi-constrained cemented prosthesis Class C A hip joint metal/composite semi-constrained cemented prosthesis is a two-part device intended to be implanted to replace a hip joint
279 Orthopaedic Implants Hip joint metal/ceramic/poly mer semi-constrained cemented or nonporous uncemented prosthesis Class C Intended to be implanted to replace a hip joint
280 Orthopaedic Implants Hip joint metal/polymer/met al semi-constrained porous-coated uncemented prosthesis. Class C Intended to be implanted to replace a hip joint
281 Orthopaedic Implants A knee joint femorotibial metallic constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint Class C Intended to be implanted to replace part of a knee joint
282 Orthopaedic Implants Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis Class C Intended to be implanted to replace a shoulder joint
283 Orthopaedic Implants Wrist joint carpal lunate polymer prosthesis Class C Intended to be implanted to replace the carpal lunate bone of the wrist.
284 Orthopaedic Implants Wrist joint metal/polymer semi-constrained cemented prosthesis Class C Intended to be implanted to replace a wrist joint.
285 Orthopaedic Implants Wrist joint metal constrained cemented prosthesis Class C Intended to be implanted to replace a wrist joint
286 Orthopaedic Implants Wrist joint polymer constrained prosthesis Class C Intended to be implanted to replace a wrist joint
287 Orthopaedic Implants Wrist joint carpal trapezium polymer prosthesis Class C Intended to be implanted to replace the carpal trapezium bone of the wrist
288 Orthopaedic Implants Wrist joint carpal scaphoid polymer prosthesis Class C Intended to be implanted to replace the carpal scaphoid bone of the wrist.
290 Orthopaedic Implants Toe joint phalangeal (hemi-toe) polymer prosthesis Class C Intended to be implanted to replace the base of the proximal phalanx of the toe.
291 Orthopaedic Implants Toe joint polymer constrained prosthesis Class C Intended to be implanted to replace the first metatarsophalangeal (big toe) joint
292 Orthopaedic Implants Shoulder joint humeral (hemi- shoulder) metallic uncemented prosthesis. Class C A shoulder joint humeral (hemi- shoulder) metallic uncemented prosthesis.
293 Orthopaedic Implants Shoulder joint glenoid (hemi- shoulder) metallic cemented prosthesis Class C It is intended to be implanted to replace part of a shoulder joint
294 Orthopaedic Implants Shoulder joint metal/polymer/metal nonconstrained or semi- constrained porous-coated uncemented prosthesis Class C It is a device intended to be implanted to replace a shoulder joint
295 Orthopaedic Implants Shoulder joint metal/polymer semi-constrained cemented prosthesis Class C Intended to be implanted to replace a shoulder joint
296 Orthopaedic Implants shoulder joint metal/polymer non-constrained cemented prosthesis Class C Intended to be implanted to replace a shoulder joint
297 Orthopaedic Implants Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis Class C Intended to be implanted to replace part of a knee joint
298 Orthopaedic Implants Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis Class C Intended to be implanted to replace the retropatellar articular surface of the patellofemoral joint
299 Orthopaedic Implants knee joint femoral (hemi-knee) metallic uncemented prosthesis Class C Intended to be implanted to replace part of a knee joint.
300 Orthopaedic Implants knee joint patellofemorotibial metal/polymer Class C Intended to be implanted to replace a knee joint
301 Orthopaedic Implants Knee joint patellofemorotibial polymer/metal/polymer semi- constrained cemented prosthesis. Class C Intended to be implanted to replace a knee joint
302 Orthopaedic Implants Knee joint patellofemorotibial polymer/metal/met al constrained cemented prosthesis Class C Intended to be implanted to replace a knee join
303 Orthopaedic Implants knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis Class C It is intended to be implanted to replace part of a knee joint in the treatment of primary patellofemoral arthritis or chondromalacia
304 Orthopaedic Implants Knee joint femorotibial (uni- compartmental) metal/polymer porous-coated uncemented prosthesis Class C Intended to be implanted to replace part of a knee joint
305 Orthopaedic Implants Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Class C Intended to be implanted to replace part of a knee joint
306 Orthopaedic Implants Knee joint femorotibial metal/polymer non-constrained cemented prosthesis Class C Intended to be implanted to replace part of a knee joint
307 Orthopaedic Implants Knee joint femorotibial metal/polymer constrained cemented prosthesis Class C Knee joint femorotibial metal/polymer constrained cemented prosthesis
308 Orthopaedic Implants Knee joint femorotibial metal/polymer constrained cemented prosthesis Class C Intended to be implanted to replace part of a knee joint.
309 Orthopaedic Implants Knee joint femorotibial metal/composite semi-constrained cemented prosthesis Class C Intended to be implanted to replace part of a knee joint
310 Orthopaedic Implants Knee joint femorotibial metal/composite non-constrained cemented prosthesis Class C Intended to be implanted to replace part of a knee joint
311 Orthopaedic Implants Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis. Class C Intended to be implanted to replace the articulating surfaces of the hip while preserving the femoral head and neck
312 Orthopaedic Implants Hip joint metal/metal semi- constrained, with a cemented acetabular component, prosthesis Class D Intended to be implanted to replace a hip joint
313 Orthopaedic Implants hip joint metal constrained cemented or uncemented prosthesis Class D Intended to be implanted to replace a hip joint
314 Orthopaedic Implants Hip joint metal/polymer constrained cemented or uncemented prosthesis Class D Intended to be implanted to replace a hip joint
315 Orthopaedic Implants Hip joint femoral (hemi-hip) metallic resurfacing prosthesis Class D Intended to be implanted to replace a hip joint
316 Orthopaedic Implants A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis Class D Intended to be implanted to replace the head and neck of the femur
317 Orthopaedic Implants A hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis Class D Intended to be implanted to replace the head and neck of the femur
318 Orthopaedic Implants Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis. Class D Intended to be implanted to replace the head and neck of the femur
319 Orthopaedic Implants A hip joint (hemi-hip) acetabular metal cemented prosthesis Class D Intended to be implanted to replace a hip joint
320 Orthopaedic Implants Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis. Class D Intended to be implanted to replace a hip joint
321 Orthopaedic Implants Plates, clipersScrews Class C rigid, limb brace, lumbar, lumbo- sacral, rib fracture, sacroiliac, thoracic oethosis.
322 Orthopaedic Implants Spinal intervertebral body fixation orthosis Class C The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.
323 Orthopaedic Implants Spinal interlaminal fixation orthosis Class C A device intended to be implanted made of an alloy, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is used primarily in the treatment of scoliosis
324 Orthopaedic Implants Resorbable calcium salt bone void filler device Class C A resorbable calcium saltbone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis
325 Orthopaedic Implants Smooth or threaded metallic bone fixation fastener Class C It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
326 Orthopaedic Implants Sacroiliac joint fixation Class C The sacroiliac joints fixation may serve as protective mechanism for the lumbosacral region.
327 Orthopaedic Implants Cervical Artificial Disc Class D Cervical Artificial Disc is indicated for reconstruction of the disc.
328 Scalp Vein Set Scalp Vein Set Class B Intended to be used for insertion into the patient’s vascular system (single use only) as an in-dwelling device to administer fluids intravenously or to sample blood.
329 Surgical Dressings Surgical Staples Class B Surgical staples are specialized staples used in surgery in place of sutures to close skin wounds, connect or remove parts of body during surgery.
330 Surgical Dressings Surgical Dressings Class A Dressing aerosol, non-adherent, dressing, periodontal, kit, dressing pad, dressing.
331 Surgical Dressings Surgical Dressings Class B Dressing-gel, dressing- permeable, moisture dressing, tracheostomy tube dressing, wound and burn dressings, hydrogel dressing, wound and burn, occlusive.
332 Surgical Dressings Cotton Grudges Adhesive bandages, Gauge bandages, Medical Absorbent (fiber) bandages.
333 Surgical Dressings Wound Dressings/Bacterio static Wound Dressings Class C Includes Beads, Hydrophilics For Wound Exudate Absorption for wound care.
334 Surgical Dressings Casting tapes/Splint Rolls Class B A prosthetic and orthotic accessory, intended for medical purposes to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis.
335 Surgical Dressings Haemostatic Gelatine Sponge /Haemostat Class C Intended for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.
336 Surgical Dressings Surgical Dressings Class C Material dressing, surgical, polylactic acid dressings.
337 Surgical Dressings Absorable Hemostatic Based Class D An absorbable haemostatic agent or dressing is a device intended to produce haemostasis by accelerating the clotting process of blood. It is absorbable.
338 Surgical Dressings Umbilical occlusion device Class A These devices may be a clip, tie, tape, or other article used to close the blood vessels in the umbilical cord of a newborn infant.
339 Surgical Dressings Bolster Suture Class A Non-latex plastic bolsters are used to hinder pressure of any temporary suture against the body during surgery.
340 Surgical Dressings Suture Non Absorable Synthetic Class C Non-absorbable suture is comprised of surgical steel as well as synthetic non- absorbable sutures for use in general soft tissue approximation and ligation.
341 Surgical Dressings Suture Absorable Class C The device is intended for use in general soft tissue approximation and ligation.
342 Surgical Dressings Endovascular suturing system Class C It is a medical device intended to provide fixation and sealing between an endovascular graft and the native artery.
343 Surgical Dressings Fixation, non- absorbable for pelvic use Class C Attaching suture or stapling ligaments of the pelvic floor.
344 Surgical Dressings Tissue adhesive for the topical use Class C Intended for topical closure of surgical incisions including laparoscopic incisions and simple traumatic lacerations.
345 Surgical Dressings Tissue adhesive for non-topical use Class D Intended for use in adhesion of internal tissues and vessels, for example; adhesives used in the embolization of brain arteriovenous malformation or for use in ophthalmic surgery.
346 Surgical Dressings Alcohol Swabs Class A It is a single use, sterile device containing 70% Isopropyl alcohol used for scrubbing and allowing drying and will disinfect needless access sites prior to use..
347 Surgical Dressings Ligature Wire Class B offer a spot-welded auxiliary hook which may be added to any bracket by simply tying in the arch wire
348 Surgical Dressings Surgical Sealant Class B For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
349 Surgical Dressings Wound Closure Device Class B Wound Closure Devices are indicated for soft tissue approximation.
350 Surgical Dressings Intracardiac patch Class D intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.
  • List of In Vitro Diagnostics Medical Devices under provisions of sub-rule

(2) rule 4 of the Medical Devices Rules, 2017

 

S. N. Category in vitro diagnostic medical device Risk Class Intended use
1 Clinical Chemistry Reagents/ Kits for estimation of various Parameters exemplified as: Acid Phosphatase (total or prostatic) test reagents/kits Class B An acid phosphatase (total or prostatic) test reagent/kit is a medical device, intended for the estimation of acid phosphatase in serum/plasma.
2 Albumin test reagents/kits Class B An albumin test reagent/kit is a medical device intended for the estimation of albumin in serum/plasma.
3 Alkaline phosphatase or isoenzymes test reagents/kits Class B An alkaline phosphatase or isoenzymes test reagent/kit is a medical device intended for the estimation of alkaline phosphatase or its isoenzymes in serum/plasma.
4 Ammonia test reagents/kits Class B An ammonia test reagent/kit is a medical device intended for the estimation of ammonia levels in blood, serum/plasma.
5 Amylase test reagents/kits Class B An amylase test reagent/kit is a medical device intended for the estimation of the enzyme amylase in serum, saliva / urine.
6 Bicarbonate / carbon dioxide test reagents/kits Class B A bicarbonate/carbon dioxide test reagent/kit s a medical device for the estimation of bicarbonate/carbon dioxide in plasma, serum/whole blood.
7 bilirubin (total and direct) test reagents/kits Class B A bilirubin (total and direct) test reagent/kit is a medical device intended for the estimation of bilirubin (total and direct) in serum/plasma.
8 Calcium test reagents/kits Class B A calcium test reagent/kit is a medical device intended for the estimation of total calcium in serum.
9 Chloride test reagents/kits Class B A chloride test reagent/kit is a medical device intended for the estimation of chloride in plasma, serum, sweat /urine.
10 cholesterol (total) test reagents/kits Class B A cholesterol (total) test reagent/kit is a medical device intended for the estimation of cholesterol in serum or plasma.
11 HDL cholesterol test reagents/kits Class B A HDL cholesterol test reagent/kit is a medical device intended for the estimation of HDL cholesterol in serum / plasma.
12 LDL cholesterol test reagents/kits Class B A LDL cholesterol test reagent/kit is a medical device intended for the estimation of LDL cholesterol in serum/plasma.
13 Lipoproteinstest reagents/kits Class B A lipoprotein test reagent/kit is a medical device intended for the estimation of lipoproteins in serum / plasma.
14 Cholinesterase test reagents/kits Class B A cholinesterase test reagent/kit is a medical device intended for the estimation of cholinesteral in serum /plasma. .
15 Creatine Kinase and its isoenzymestest reagents/kits Class B A creatine phosphokinase/creatine kinase or isoenzymes including CKMB, CKBB and CKMM test reagent/kit is a medical device intended for the estimation of the enzyme creatine phosphokinase or its isoenzymes in serum / plasma. .
16 Copper test reagents/kits Class B Copper test reagent/kit is a medical device intended for the estimation of copper in plasma, serum / urine.
17 Creatinine test reagents/kits Class B A creatinine test reagent/kit is a medical device intended for the estimation of creatinine in serum, plasma / urine.
18 Gamma GlutamylTransferase (GGT) and isoenymes test reagents/kits Class B A Gamma Glutamyl Transferase (GGT) and isoenzymes test reagent/kit is a medical device intended for the estimation of the enzyme Gamma GlutamylTransferase (GGT) in serum / plasma.
19 Glucose test reagents/kits Class B A Glucose test reagent/kit is a medical device intended for the estimation of glucose in blood/plasma/ body fluids.
20 Glucose-6-Phosphate Dehydrogenase (G6PD) and its isoenzymes test reagents/kits Class B A Glucose-6-Phosphate Dehydrogenase(G6PD)test reagents/kit is a medical device intended for the estimation of Glucose-6-Phosphate Dehydrogenase or its isoenzymes in serum / plasma. .
21 Glycosylated Hemoglobin or its variants test reagents/kits Class B Glycosylated Hemoglobin or its variants test reagents/kits are medical devices intended for the estimation of glycosylated hemoglobin or its variants including A1a, A1b, and A1c in blood.
22 Hemoglobin test reagents/kits Class B A hemoglobin test reagent/kit is a medical device intended for the estimation of hemoglobin in blood.
23 Iron test reagents/kits Class B An iron test reagent/kit is a medical device intended for the estimation of iron in serum /plasma.
24 Ferritin test reagents/kits Class B An Ferritin test reagent/kit is a medical device intended for the estimation of ferritin in serum / plasma
25 Iron-binding capacity test reagents/kits Class B Iron-binding capacity test reagents/kits are medical devices intended for the estimation of iron- binding capacity in serum / plasma.
26 Lactate Dehydrogenase and its isoenzymes test reagents/kits Class B A Lactate Dehydrogenase and its isoenzymes test reagent/kit is a medical device intended for the estimation of enzyme Lactate Dehydrogenase and its isoenzymes in serum / plasma.
27 Lipase test reagents/kits Class B A lipase test reagent/kit is a medical device intended for the estimation of lipase in serum / plasma.
28 Magnesium test reagents/kits Class B A magnesium test reagent/kit is a medical device intended for the estimation of magnesium levels in serum / plasma.
29 Phosphorus (inorganic) test reagents/kits Class B A phosphorus (inorganic) test reagent/kit is a medical device intended for the estimation of inorganic phosphorus in serum, plasma / urine.
30 Potassium test reagents/kits Class B A potassium test reagent/kit is a medical device intended for the estimation of potassium in serum, plasma / urine.
31 Aspartate Amino Transferase (AST/SGOT) test reagents/kits Class B An Aspartate Amino Transferase (AST/SGOT) test reagent/kit is a medical device intended for the estimation of the enzyme Aspartate Amino Transferase (AST/SGOT) in serum / plasma.
32 Alanine Amino Transferase (ALT/SGPT) test reagents/kits Class B An Alanine Amino Transferase (ALT/SGPT) test reagent/kit is a medical device intended for the estimation of enzyme Alanine Amino Transferase (ALT/SGPT) in serum / plasma.
33 Sodium test reagents/kits Class B A Sodium test reagent/kit is a medical device intended for the estimation of sodium in serum/ plasma / urine.
34 Total protein test reagents/kits Class B A Total Protein test reagent/kit is a medical device intended for the estimation of total protein(s) in serum / plasma.
35 Protein (fractionation) test reagents/kits Class B A Protein (fractionation) test reagent/kit is a medical device intended for the estimation of protein fractions in blood, urine, cerebrospinal fluid / other body fluids.
36 Protein-bound iodine test reagents/kits Class B A Protein-bound iodine test reagent/kit is a medical device intended for the estimation of protein-bound iodine in serum / plasma.
37 Triglycerides test reagents/kits Class B A Triglyceride test reagent/kit is a medical device intended for the estimation of triglycerides in serum / plasma.
38 Urea (BUN) test reagents/kits Class B A Urea (BUN) test reagent/kit is a medical device intended for the estimation of urea/Blood Urea Nitrogen (BUN) in plasma/ serum / urine.
39 Uric Acid test reagents/kits Class B A Uric Acid test reagent/kit is a medical device intended for the estimation of uric acid in serum/ plasma / urine.
40 Micro-Protein test reagents/kits Class B A Micro-protein test reagent/kit is a medical device intended for the estimation of micro-proteins including micro-albumin in urine.
41 Zinc test reagents/kits Class B A Zinc test reagent/kit is a medical device intended for the estimation of zinc in serum / plasma.
42 Other clinical chemistry test reagents/kits Class B* Clinical chemistry test reagent/kit intended for the estimation of analytes/ parameters (other than listed above) in serum/ plasma/ urine or other body fluids.
43 Hematology Reagents/ Kits for estimation of Complete Blood Counts, exemplified as: Blood cell Diluents Class B A blood cell Diluent is a medical device used to dilute blood for further testing, such as Complete Blood Count(CBC) .
44 Lyse reagents/kits for differential counts Class B A Lyse reagent/kit is a medical device used for lysing of cells for the estimation of Complete Blood Count(CBC).
45 Rinse/Detergent/Cleaner s reagents/kits Class B A Rinse/Detergent/Cleaner reagent/kit is a medical device used for cleaning various parts of Hematology analyzers like probes, needles, baths, tubing etc.
46 Reagents/ Kits for estimation of parameters in the urine, exemplified as: Ascorbic Acid/ Bilirubin /Blood Cells/Glucose/ Ketone / Leukocyte peroxidase / Specific gravity/Urobilinogen Nitrite / pH / Protein /Albumin & other urinary analytes test reagents /Strips/kits Class B Ascorbic Acid/ Bilirubin /Blood Cells/Glucose/ Ketone / Leukocyte peroxidase / Specific gravity/Urobilinogen Nitrite/pH /Protein / Albumin & other urinary analytes test reagents /Strips/kits, are medical devices intended for the preliminary estimation of diagnostic markers in urine.
47 In – vitro
Diagnostic Medical Devices for Self -Testing
Glucose test reagents/kits Class B A glucose is a medical reagents/kits device intended for the preliminary self testing of glucose levels in blood/body fluids.
48 Human Chorionic Gonadotropin (hCG) test reagents/kits Class B A human Chorionic Gonadotropin (hCG) test reagent/kit is a medical device intended for the preliminary self testing of hCG in urine/body fluids.
49 Luteinizing Hormone (LH) test reagents/kits Class B A Luteinizing Hormone (LH) test reagent/kit is a medical device intended for the preliminary self testing of Luteinizing Hormone (LH) in urine/body fluids.
50 Glycosylated hemoglobinor ist variants Test reagents/kits Class B Glycosylated Hemoglobin or its variants test reagents/kits are medical devices intended for the preliminary self testing of Glycosylated Hemoglobin or its variants including A1a, A1b, and A1c in blood.
51 Cholesterol test reagents/kits Class B A Cholesterol test reagent/kit is a medical device intended for preliminary self testing of cholesterol in blood /body fluids.
52 Follicle Stimulating Hormone (FSH) test reagents/kits Class B A Follicle Stimulating Hormone (FSH) test reagent/kit is a medical device intended for the preliminary self testing of Follicle Stimulating Hormone (FSH) in urine /body fluids
53 Other In – vitro Diagnostic Medical Devices for Self – Testing Class B*
54 In – vitro
Diagnostic Medical Device for 55. near patient testing
55 Blood Gas Analysis test reagents/kits Class C A Blood Gas Analysis test reagent/kit for near patient testing, is a medical device intended for the estimation of certain gases (such as oxygen and carbon dioxide etc.) dissolved in arterial blood.
56 Anticoagulant monitoring test reagents/kits Class C An Anticoagulant monitoring test reagent/kit for near patient testing, is a medical device intended for the estimation of coagulation parameters (such as PT, TT, APTT etc.) in plasma/blood.
57 Diabetes management test reagents/kits Class C A Diabetes management test reagent/kit for near patient testing, is a medical device intended for the of monitoring of diabetes in body fluids.
58 C- Reactive Protein (CRP)test reagents/kits Class C A C- Reactive Protein (CRP) test/kits reagent/kit for near patient testing, is a medical device intended for the estimation of C -Reactive Protein (CRP) in serum and other body fluids
59 H. pylori test reagents/kits Class C An H. pylori test reagent/kit for near patient testing, is a medical device
intended for the estimation of H. pylori in blood/body fluids.
60 Troponin test reagents/kits Class C A Troponin test reagent/kit for near patient testing, is a medical device
intended for the estimation of Troponin T,I and its variants in blood/body fluids
61 Other in vitro Diagnostic Medical Devices for near patient test reagents/kits Class C In vitro Diagnostic Medical Device for near patient test reagent/kit intended for the estimation of analytes/ parameters (other than listed above) in serum, plasma, urine or other body fluids.
62 Reagents/ Kits for estimation of parameters of ToRCH& other infectious agents exemplified as under: Toxoplasma gondii test reagents/kits Class C A Toxoplasma gondii test reagent/kit is a medical device intended for the detection of Toxoplasma gondii in serum/body fluids.
63 Rubella virus l test reagents/kits Class C A Rubella virus test reagent/kit is a medical device intended for the detection of Rubella virus in serum/body fluids.
64 Cytomegalovirus test reagents/kits Class C A Cytomegalovirus test reagent/kit is a medical device intended for the detection of Cytomegalovirus in serum/body fluids.
65 Herpes simplex virus reagents/kits Class C A Herpes simplex virus reagent/kit is a medical device intended for the detection of Herpes simplex virus in serum/body fluids.
66 Chlamydia pneumoniae test reagents/kits Class C A Chlamydia pneumoniae test reagent/kit is a medical device intended for the detection of Chlamydia pneumonia in serum/body fluids.
67 Methicillin-Resistant Staphylococcus aureus test reagents/kits Class C A Methicillin-Resistant Staphylococcus aureus test reagent/kit is a medical device intended for the detection of Methicillin-Resistant Staphylococcus aureus in serum/body fluids
68 Enterovirus test reagents/kits Class C An Enterovirus test reagent/kit medical device intended for the detection of enterovirus) serum/body fluids.
69 Reagents/ Kits for detection of Cancer Markers exemplified as : Alpha-fetoprotein test reagents/kits Class C An Alpha-fetoprotein test reagent/kit is a medical device intended for the detection of Alpha-fetoprotein in serum/body fluids.
70 Beta-2 microglobulin test reagents/kits Class C A Beta-2 microglobulin test reagent/kit is a medical device intended for the detection of Beta-2 microglobulin in serum/body fluids
71 Bladder tumour antigen (BTA) test reagents/kits Class C A Bladder tumour antigen (BTA) test reagent/kit is a medical device intended for the detection of Bladder tumour antigen (BTA)in serum/body fluids
72 CA15-3 test reagents/kits Class C A CA15-3 antigen (BTA) test reagent/kit is a medical device intended for the detection of CA15-3 in serum/body fluids
73 CA27.29 test reagents/kits Class C A CA27.29 test reagent/kit is a medical device intended for the detection of CA27.29 in serum/body fluids
74 CA125 test reagents/kits Class C A CA125test reagent/kit is a medical device intended for the detection of CA125 in serum/body fluids
75 CA72-4 test reagents/kits Class C A CA72-4 test reagent/kit is a medical device intended for the detection of CA72-4 in serum/body fluids
76 CA19-9 test reagents/kits Class C A CA19-9 test reagent/kit is a medical device intended for the detection of CA19-9 in serum/body fluids
77 Calcitonin test reagents/kits Class C A Calcitonin test reagent/kit is a medical device intended for the detection of Calcitonin in serum/body fluids
78 Carcinoembryonic antigen (CEA) test reagents/kits Class C A Carcinoembryonic antigen (CEA) test reagent/kit is a medical device intended for the detection of Carcinoembryonic antigen (CEA) in serum/body fluids
79 Chromogranin A test reagents/kits Class C A Chromogranin A test reagent/kit is a medical device intended for the detection of Chromogranin A in serum/body fluids
80 Estrogen / Progesterone receptors test reagents/kits Class C A Estrogen / Progesterone test reagent/kit is a medical device intended for the detection of Estrogen / Progesterone in serum/body fluids
81 HER2 (Human Epidermal Growth Factor receptor, test reagents/kits Class C A HER2 (Human Epidermal Growth Factor receptor test reagent/kit is a medical device intended for the detection of HER2 (Human Epidermal Growth Factor receptor in serum/body fluids
82 human Chorionic Goadotropin (hCG) test system test reagents/kits Class C A human Chorionic Goadotropin (hCG) test reagent/kit is a medical device intended for the detection of human Chorionic Goadotropin (hCG) in serum/body fluids
83 Lipid associated sialic acid test reagents/kits Class C A Lipid associated sialic acid test reagent/kit is a medical device intended for the detection of Lipid associated sialic acid in serum/body fluids
84 Neuron -Specific Enolase (NSE) test reagents/kits Class C A Neuron -Specific Enolase (NSE) test reagent/kit is a medical device intended for the detection of Neuron -Specific Enolase (NSE) in serum/body fluids
85 NMP22 test reagents/kits Class C A NMP22 test reagent/kit is a medical device intended for the detection of NMP22 in serum/body fluids
86 Prostate-Specific Antigen (PSA) test reagents/kits Class C A Prostate-Specific Antigen (PSA) test reagent/kit is a medical device intended for the detection of Prostate-Specific Antigen (PSA) in serum/body fluids
87 Prostatic Acid Phosphatase (PAP) test reagents/kits Class C A Prostatic Acid Phosphatase (PAP) test reagents/kits test reagent/kit is a medical device intended for the detection of Prostatic Acid Phosphatase (PAP) test reagents/kits in serum/body fluids
88 Prostate Cancer Antigen 3 gene (PCA 3) test reagents/kits Class C A Prostate Cancer Antigen 3 gene (PCA 3) test reagent/kit is a medical device intended for the detection of Prostate Cancer Antigen 3 gene (PCA 3) in serum/body fluids
89 Prostate-Specific Membrane Antigen (PSMA) test reagents/kits Class C A Prostate-Specific Membrane Antigen (PSMA) test reagent/kit is a medical device intended for the detection of Prostate-Specific Membrane Antigen (PSMA) in serum/body fluids
90 S-100 test reagents/kits Class C A S-100 test reagent/kit is a medical device intended for the detection of S-100 in serum/body fluids
91 TA-90 test reagents/kits Class C A TA-90 test reagent/kit is a medical device intended for the detection of TA-90 in serum/body fluids
92 Thyroglobulin test reagents/kits Class C A Thyroglobulin test reagent/kit is a medical device intended for the detection of Thyroglobulin in serum/body fluids
93 Tissue Polypeptide Antigen (TPA) test reagents/kits Class C A Tissue Polypeptide Antigen (TPA) test reagent/kit is a medical device intended for the detection of Tissue Polypeptide Antigen (TPA) in serum/body fluids
94 Other Reagents/ Kits for detection of Cancer Markers Class C*
95 Reagents/ Kits for estimation of Coagulation parameters exemplified as: PT (Prothrombin Time) test reagents/kits Class C A Prothrombin Time (PT)test reagent/kit is a medical device intended for the estimation of prothrombin time in plasma/body fluids.
96 TT (Thrombin Time) test reagents/kits Class C A Thrombin Time(TT)test reagent/kit is a medical device intended for the estimation of Thrombin Time in plasma/body fluids
97 Activated Partial Thromboplastin Time(APTT) testsreagents/kits Class C A Activated Partial ThromboplastinTime (APTT) test reagent/kit is a medical device intended for the estimation of Activated Partial ThromboplastinTime in plasma/body fluids
98 Activated whole blood clotting time tests reagents/kits Class C A Activated whole blood clotting time test reagent/kit is a medical device intended for the estimation of Activated whole blood clotting Time in plasma/body fluids
99 Fibrinogen/Fibrin degradation products tests reagents/kits Class C A Fibrinogen/Fibrin degradation products test reagent/kit is a medical device intended for the estimation of fibrinogen/fibrin degradation products
100 D-Dimer tests reagents/kits Class C A D-Dimer test reagent/kit is a medical device intended for the estimation of D-Dimer test in plasma/body fluids
101 Other Reagents/ Kits for estimation of Coagulation parameters Class C*
102 Reagents/ Kits for monitoring of drug levels used for therapy or abuse exemplified as under Aminoglycoside antibiot ics test reagents/kits Class C Aminoglycoside antibiotics test reagents/kits are medical devices intended for the estimation of Aminoglycoside antibiotics in serum/body fluids.
103 Antiepileptics test reagents/kits Class C Antiepileptics test reagents/kits are medical devices intended for the estimation of Antiepileptics in serum/body fluids.
104 Antipsychotics test reagents/kits Class C Antipsychotics test reagents/kits are medical devices intended for the estimation of Antipsychotics in serum/body fluids.
105 Mood stabilisers, test reagents/kits Class C Mood stabilisers test reagents/kits are medical devices intended for the estimation of Mood stabilisers in serum/body fluids
106 Biologic monoclonal antibody drugs test reagents/kits Class C Biologic monoclonal antibody drugs test reagents/kits are medical devices intended for the estimation of Biologic monoclonal antibody drugs in serum/body fluids
107 Buprenorphine (BUP) test reagents/kits Class C Buprenorphine (BUP) test reagents/kits are medical devices intended for the estimation of Buprenorphine (BUP) in serum/body fluids
108 Amphetamine (AMP) test reagents/kits Class C Amphetamine (AMP) test reagents/kits are medical devices intended for the estimation of Amphetamine (AMP) in serum/body fluids
109 Barbiturates ( BAR) test reagents/kits Class C Barbiturates (BAR) test reagents/kits are medical devices intended for the estimation of Barbiturates (BAR) in serum/body fluids
110 Opiate test system test reagents/kits Class C Opiate test reagents/kits are medical devices intended for the estimation of opiates in serum/body fluids
111 Benzodiazepines (BZO)Test reagents /kits Class C Benzodiazepines (BZO) test reagents/kits are medical devices intended for the estimation of Benzodiazepines (BZO) in serum/body fluids
112 Cocaine (COC) Test reagents /kits Class C Cocaine (COC) test reagents/kits are medical devices intended for the estimation of Cocaine (COC)in serum/body fluids
113 Cotinine (COT) Test reagents /kits Class C Cotinine (COT) test reagents/kits are medical devices intended for the estimation of Cotinine (COT) in serum/body fluids
114 Ketamine ( KET )Test reagents /kits Class C Ketamine (KET) test reagents/kits are medical devices intended for the estimation of Ketamine ( KET )in serum/body fluids
115 Ecstasy ( MDMA ) Test reagents /kits Class C Ecstasy ( MDMA ) test reagents/kits are medical devices intended for the estimation of Ecstasy ( MDMA )in serum/body fluids
116 Methamphetamine ( MET )Test reagents /kits Class C Methamphetamine ( MET ) test reagents/kits are medical devices intended for the estimation of Methamphetamine (MET) in serum/body fluids
117 Morphine ( MOP )Test reagents /kits Class C Morphine (MOP) test reagents/kits are medical devices intended for the estimation of Morphine (MOP) in serum/body fluids
118 Methaqualone (MQL)Test reagents /kits Class C Methaqualone (MQL) test reagents/kits are medical devices intended for the estimation of Methaqualone (MQL)in serum/body fluids
119 Methadone ( MTD) Test reagents /kits Class C Methadone (MTD)test reagents/kits are medical devices intended for the estimation of Methadone ( MTD )in serum/body fluids
120 Oxycodone (OXY)Test reagents /kits Class C Oxycodone (OXY) test reagents/kits are medical devices intended for the estimation of Oxycodone (OXY) in serum/body fluids
121 Phencyclidine ( PCP ) Test reagents /kits Class C Phencyclidine (PCP) test reagents/kits are medical devices intended for the estimation of Phencyclidine (PCP)in serum/body fluids
122 Propoxyphene ( PPX ) Test reagents /kits Class C Propoxyphene (PPX) test reagents/kits are medical devices intended for the estimation of Propoxyphene (PPX) in serum/body fluids
123 Tricyclic Antidepressants (TCA)Test reagents /kits Class C Tricyclic Antidepressants (TCA) test reagents/kits are medical devices intended for the estimation of Tricyclic Antidepressants (TCA) in serum/body fluids
124 Marijuana (THC)Test reagents /kits Class C Marijuana (THC) test reagents/kits are medical devices intended for the estimation of Marijuana (THC) in serum/body fluids
125 Tramadol (TRA ) Test reagents /kits Class C Tramadol (TRA) test reagents/kits are medical devices intended for the estimation of Tramadol (TRA) in serum/body fluids
126 Fentanyl (FEN)Test reagents /kits Class C Fentanyl (FEN) test reagents/kits are medical devices intended for the estimation of Fentanyl (FEN) in serum/body fluids
127 Methadone Metabolite (EDDP)Test reagents /kits Class C Methadone Metabolite (EDDP) test reagents/kits are medical devices intended for the estimation of Methadone Metabolite ( EDDP )in serum/body fluids
128 Other Reagents/ Kits for monitoring of drug levels used for therapy or abuse Class C*
129 Reagents/Kits for detection of autoimmune disorders exemplified as: Anti Nuclear Antibodies test reagents/kits Class B Anti Nuclear Antibodies test reagent/kit is a medical device for the screening of auto-antibodies to nuclear antigens in human specimens.
130 Anti Transglutaminase Antibodies test reagents/kits Class B Anti Transglutaminase Antibodies test reagent/kit is a medical device for the screening of auto-antibodies to Transglutaminase in human specimens.
131 Anti Ganglioside Antibodies test reagents/kits Class B Anti Ganglioside Antibodies test reagent/kit is a medical device for the screening of auto-antibodies to Ganglioside in human specimens
132 Anti-Cyclic Citrullinated Peptide (CCP) Antibodies test reagents/kits Class B Anti CyclicCitrullinated Peptide (CCP) Antibodies test reagent/kit is a medical device for the screening of CCP auto-antibodies in human specimens.
133 Rheumatoid Factor (RF) immunological test reagents/kits Class B Rheumatoid Factor (RF) immunological test reagent/kit is a medical device for the screening of Rheumatoid Factor in human specimens.
134 Anti Smooth Muscle Antibody test reagents/kits Class B Anti Smooth Muscle Antibody test reagent/kit is a medical device for the screening of auto-antibodies to smooth muscles in human specimens.
135 Glutamic Acid Decarboxylase (GAD) Antibody test reagents/kits Class B Glutamic Acid Decarboxylase (GAD) Antibodytest reagent/kit is a medical device for the screening of auto- antibodies to Glutamic Acid Decarboxylase (in human specimens
136 Anti ovary antibodies test reagents/kits Class B Anti ovary antibodies test reagent/kit is a medical device for the screening of auto-antibodies to ovarian antigens in human specimens
137 Anti sperm Antibodies test reagents/kits Class B Anti sperm antibodies test reagent/kit is a medical device for the screening of auto-antibodies to spermatozoa in human specimens.
138 Anti-IA2 test reagents/kits Class B Anti IA-2 antibodies test reagent/kit is a medical device for the screening of auto-antibodies to IA-2 (tyrosine phosphatase) in human specimens
139 Anti-Acetylcholine test reagents/kits Class B Anti-Acetylcholine Receptor test Receptor reagent/kit is a medical device for the screening of auto-antibodies to Acetylcholine Receptor in human specimens
140 Anti Thyroid gland test reagents/kits Class B Anti Thyroid gland antibodies test antibody reagent/kit is a medical device for the screening of auto-antibodies to thyroid gland antigens in human specimens
141 ANCA test reagents/kits Class B The ANCA test reagent/kit is a medical device for the screening of Anti-Neutrophil Cytoplasmic Antibodies (ANCA) in human specimens.
142 Anti-double stranded DNA (anti-dsDNA)test reagents/kits Class B The Anti-double stranded DNA (Anti-dsDNA) test reagent/kit is a medical device for the screening of auto-antibodies to Double stranded DNA in human specimens
143 Anti-Extractable Nuclear Antigen(Anti-ENA)test reagents/kits Class B The Anti-Extractable Nuclear Antigen(Anti-ENA)test reagent/kit is a medical device for the screening of auto-antibodies to Extractable Nuclear Antigens like Smith (Sm) Antigens, Ribonuclears Protein (RNP), anti SSA (Ro) etc. in human specimens.
144 Anti-Intrinsic Factor test reagents/kits Class B The Anti-Intrinsic Factor test reagent/kit is a medical device for the screening of antibodies against intrinsic factor in human specimens.
145 Anti-Saccharomyces Cerevisiae Antibodies (ASCA) test reagents/kits Class B The Anti-Saccharomyces Cerevisiae Antibodies (ASCA) test reagent/kit is a medical device for the screening of antibodies against Saccharomyces Cerevisiae in human specimens.
146 Other Reagents/ Kits for detection of autoimmune disorders Class B*
147 Reagents/Kits for detection of markers for Congenital disorders exemplified as under
148 Triple Screen Test reagents/kits for Down’s Syndrome Class C Triple Screen Test reagent/kit for Down’s Syndrome is a medical device intended for the screening of Down’s Syndrome in serum/plasma.
149 Quadruple Screen Test reagents/kits for Down’s Syndrome Class C Quadruple Screen Test reagent/kit for Down’s Syndrome is a medical device intended for the screening of Down’s Syndrome in serum/plasma
150 Chorionic Villus Sample Test reagents/kits for Down’s Syndrome Class C Chorionic Villus Sample Test reagent/kit for Down’s Syndrome is a medical device intended for the detection of Down’s Syndrome in body fluids.
151 Maternal Serum Alpha- Fetoprotein (MSAFP) test reagents/kits for spina bifida Class C Maternal Serum Alpha-Fetoprotein (MSAFP) Test reagents/kits for is a medical device intended for the screening of spina bifida in serum.
152 Others Reagents/ Kits for detection of Congenital disorders Class C*
153 Reagents/Kits for detection of Cardiac Markers exemplified as under Creatine Kinase (CK) and CKMB test reagents/kits Class B Creatine Kinase (CK) and CKMB test reagent/kit are medical devices intended for the estimation of Creatine Kinase (CK) and CKMB in blood / body fluids.
154 Myoglobin test reagents/kits Class B Myglobin Test reagent/kit for is a medical device intended for the estimation of myglobin in blood /body fluids.
155 Troponin test reagents/kits Class C A Troponin test reagent/kit for near patient testing, is a medical device intended for the estimation of Troponin T,I and its variants in blood /body fluids
156 BNP &NT pro BNP test reagents/kits Class C BNP &NT pro BNP Test reagent/kit for is a medical device intended for theestimation of BNP &NT pro BNP in blood / body fluids
157 Reagents/ Kits for human Genetic testing exemplified as: Genetic test reagents/kits for Cystic Fibrosis Class C Genetic test reagent/kit for Cystic Fibrosis is a medical device intended for the detection of Cystic Fibrosis in human specimens.
158 Genetic test for Huntington’s chorea Class C Genetic test reagent/kit for Huntington’s chorea is a medical device intended for the detection of Huntington’s chorea in human specimens.
159 Other Reagents/ Kits for human Genetic testing Class C*
160 Reagents/ Kits for the management of life threatening infections exemplified as: HIV Viral Load test reagents/kits Class C HIV Viral Load test reagent/kit is a medical device intended for the estimation of HIV Viral Load in blood/body fluids
161 HBV Viral Load test reagents/kits Class C HBV Viral Load test reagent/kit is a medical device intended for the estimation of HIV Viral Load in blood/body fluids
162 HCV Viral Load test reagents/kits Class C HCV Viral Load test reagent/kit is a medical device intended for the estimation of HIV Viral Load in blood/body fluids
163 CD4 Count & % test reagents/kits Class C CD4 Count & % test reagent/kit is a medical device intended for the estimation of CD4 Count & % in blood/body fluids.
164 CD8 Count & % test reagents/kits Class C CD8 Count & % test reagent/kit is a medical device intended for the estimation of CD8 Count & % in blood/body fluids.
165 CD4/CD8 Ratio test reagents/kits Class C CD4/CD8 Ratio test reagent/kit are a medical device intended for the estimation of CD4/CD8 Ratio in blood/body fluids.
166 Other Reagents/ Kits for the management of life threatening infections Class C*
167 Reagents/ Kits for the detection of sexually transmitted agent exemplified a under Treponema pallidum test reagents and kits Class C Treponema pallidum test reagent/kit is a medical device intended for the detection of Treponema pallidum in blood/body fluids.
168 Neisseria gonorrhoeae test reagents and kits Class C Neisseria gonorrhoeae test reagent/kit is a medical device intended for the detection of Neisseria gonorrhoeae in blood/body fluids
169 Human Papilloma Virus (HPV) test reagents and kits Class C Human Papilloma Virus (HPV) test reagent/kit is a medical device intended for the detection of Human Papilloma Virus in blood/body fluids
170 Chlamydia test reagents and kits Class C Chlamydia test reagent/kit is medical device intended for the detection of Chlamydia blood/body fluids
171 Herpes Virus test reagents and kits Class C Herpes Virus test reagent/kit is a medical device intended for the detection of Herpes Virus in blood/body fluids
172 Other Reagents/ Kits for the detection of sexually transmitted agent Class C*
173 Reagents/ Kits for the Antigen detection of infectious agents with a risk of limited propagation exemplified
as:
174 Malaria Antigen test reagents and kits Class C Malaria Antigen test reagent/kit is a medical device intended for the detection of Malaria Antigen in blood/body fluids
175 Dengue virus Antigen test reagents and kits Class C Dengue virus Antigen test reagent/kit is a medical device intended for the detection of Dengue virus Antigen in blood/body fluids
176 Chikungunya Antigen test reagents and kits Class C Chikungunya Antigen test reagent/kit is a medical device intended for the detection Chikungunya Antigen of in blood/body fluids
177 Leptospira Antigen test reagents and kits Class C Leptospira Antigen test reagent/kit is a medical device intended for the detection of Leptospira Antigen in blood/body fluids
178 Japanese Encephalitis Antigen test reagents and kits Class C Japanese Encephalitis Antigen test reagent/kit is a medical device intended for the detection of Japanese Encephalitis Antigen in blood/body fluids
179 Typhoid Antigens test reagents and kits Class C Typhoid Antigens Test reagent/kit is a medical device intended for the Detection of Typhoid Antigens in blood/body fluids
180 Influenza A Antigen test reagents and kits Class C Influenza A Antigen test reagent/kit is a medical device intended for the detection of Influenza A Antigen in blood/body fluids
181 Influenza B Antigen test reagents and kits Class C Influenza B Antigen test reagent/kit is a medical device intended for the detection of Influenza B Antigen in blood/body fluids
182 Strep A Antigen test reagents and kits Class C Strep A Antigen test reagent/kit is a medical device intended for the detection of Strep A Antigen in blood/body fluids
183 Strep B Antigen test reagents and kits Class C Strep B Antigen test reagent/kit is a medical device intended for the detection of Strep B Antigen in blood/body fluids
184 Chagas Antigen test reagents and kits Class C Chagas Antigen test reagent/kit is a medical device intended for the detection of Chagas Antigen in blood/body fluids
185 Filariasis Antigen test reagents and kits Class C Filariasis Antigen test reagent/kit is a medical device intended for the detection of Filariasis Antigen in blood/body fluids
186 Kala Azar Antigen test reagents and kits Class C Kala Azar Antigen test reagent/kit is a medical device intended for the detection of Kala Azar Antigen in blood/body fluids
187 Rotavirus Antigen test reagents and kits Class C Rotavirus Antigen test reagent/kit is a medical device intended for the detection of Rotavirus Antigen in blood/body fluids
188 S. pneumonia Antigen test reagents and kits Class C S. pneumonia Antigen test reagent/kit is a medical device intended for the detection of S. pneumonia Antigen in blood/body fluids
189 H. pylori Antigen test reagents and kits Class C H. pylori Antigen test reagent/kit is a medical device intended for the detection of H. pylori Antigen in blood/body fluids
190 Other Reagents/ Kits for the detection of infectious agents with a risk of limited propagation Class C* Reagents/ Kits, other than above, for the Antigen detection of infectious agents with a risk of limited propagation
191 Reagents/ Kits for the detection of Antibodies to infectious agents with a risk of limited propagation exemplified as under
192 Malaria Antibody test reagents and kits Class B Malaria Antibody test reagent/kit is a medical device intended for the detection of Malaria Antibody in blood/body fluids
193 Dengue Antibody test reagents and kits Class B Dengue Antibody test reagent/kit is a medical device intended for the detection of Dengue Antibody in blood/body fluids
194 Chikungunya Antibody test reagents and kits Class B Chikungunya Antibody test reagent/kit is a medical device intended for the detection of Chikungunya Antibody in blood/body fluids
195 Leptospira Antibody test reagents and kits Class B Leptospira Antibody test reagent/kit is a medical device intended for the detection of Leptospira Antibody in blood/body fluids
196 Japanese Encephalitis Antibody test reagents and kits Class B Japanese Encephalitis Antibody test reagent/kit is a medical device intended for the detection of Japanese Encephalitis Antibody in blood/body fluids
197 Typhoid Antibody test reagents and kits Class B Typhoid Antibody test reagent/kit is a medical device intended for the detection of Typhoid Antibody in blood/body fluids
198 Cryptococcus neoformans Antibody test reagents and kits Class B Cryptococcus neoformans Antibody test reagent/kit is a medical device intended for the detection of Cryptococcus neoformans Antibody in blood/body fluids
199 Neisseria meningitides Antibody test reagents and kits Class B Neisseria meningitides Antibody test reagent/kit is a medical device intended for the detection of Neisseria meningitides Antibody in blood/body fluids
200 Vibrio cholera Antibody test reagents and kits Class B Vibrio cholera Antibody test reagent/kit is a medical device intended for the detection of Vibrio cholera Antibody in blood/body fluids
201 Influenza A Antibody test reagents and kits Class B Influenza A Antibody test reagent/kit is a medical device intended for the detection of Influenza A Antibody in blood/body fluids
202 Influenza B Antibody test reagents and kits Class B Influenza B Antibody test reagent/kit is a medical device intended for the detection of Influenza B Antibody in blood/body fluids
203 Strep A Antibody test reagents and kits Class B Strep A Antibody test reagent/kit is a medical device intended for the detection of Strep A Antibody in blood/body fluids
204 Strep B Antibody test reagents and kits Class B Strep B Antibody test reagents/kits is a medical device intended for the detection of Strep B Antibody in blood/body fluids
205 Chagas Antibody test reagents and kits Class B Chagas Antibody test reagent/kit is a medical device intended for the detection of Chagas Antibody in blood/body fluids
206 Filariasis Antibody test reagents and kits Class B Filariasis Antibody test reagent/kit is a medical device intended for the detection of Filariasis Antibody in blood/body fluids
207 Kala Azar Antibody test reagents and kits Class B Kala Azar Antibody test reagents/kits is a medical device intended for the detection of Kala Azar Antibody in blood/body fluids
208 Rotavirus Antibody test reagents and kits Class B Rotavirus Antibody test reagents/kits is a medical device intended for thedetection of Rotavirus Antibody in blood/body fluids
209 S. pneumonia Antibody test reagents and kits Class B S. pneumonia Antibody test reagent/kit is a medical device intended for the detection of S. pneumonia Antibody in blood/body fluids
210 H. pylori Antibody test reagents and kits Class B H.pylori Antibody test reagent/kit is a medical device intended for the detection of H.pylori Antibody in blood/body fluids
211 Other Reagents/ Kits for the detection of Antibodies to infectious agents with a risk of limited propagation Class B*
In vitro Diagnostic Medical Devices for Blood Grouping or Tissue Typing
212 All other than, the ABO system; the Duffy system; the Kell system; the Kidd system; the Rhesus system, test reagents/kits. Class C
213 in vitro Diagnostic Medical Devices for Blood Grouping or Tissue Typing ABO System test reagents/kits Class D Intended for blood grouping or tissue typing.
214 Rhesus (D) System test reagents/kits Class D
215 The Duffy system test reagents/kits Class D
216 The Kell system test reagents/kits Class D
217 The Kidd system test reagents/kits Class D
218 HLA test reagents/kits Class D
219 Reagents/Kits for the detection of transmissible agents – screening & confirmatory HIV test reagents/kits Class D HIV test reagents/kits is a medical device intended for the detection of HIV in blood/body fluids.
220 HBV test reagents/kits Class D HBV test reagents/kits is a medical device intended for the detection of HBV in blood/body fluids
221 HCV test reagents/kits Class D HCV test reagents/kits is a medical device intended for the detection of HCV in blood/body fluids
222 Syphilis screening reagents/kits Class D Syphilis test reagents/kits is a medical device intended for the screening of Syphilis in blood/body fluids
223 Malaria screening reagents/kits Class D Malaria test reagents/kits is a medical device intended for the screening of Malaria in blood/body fluids
224 Other in vitro Medical Devices TSH test reagents/kits Class B TSH test reagent/kit is a medical device intended for the estimation TSH in blood/body fluids.
225 Total /Free triiodothyronine (T3) test reagents/kits Class B Total /Free triiodothyronine (T3) test reagent/kit is a medical device intended for the estimation Total /Free triiodothyronine (T3) in blood/body fluids
226 Total / Free thyroxine (T4) test reagents/kits Class B Total / Free thyroxine (T4) test reagent / kit is a medical device intended for the estimation of Total / Free thyroxine (T4) in blood/body
227 Dehydroepiandrosterone (DHEA-S) (free and sulfate) test reagents/kits Class B Dehydroepiandrosterone (DHEA-S) (free and sulfate) test reagent/kit is a medical device intended for the estimation of DHEA-S (free and sulfate) in blood/body fluids
228 Estrogen test reagents/kits Class B Estrogen test reagent/kit is a medical device intended for the estimation of Estrogen in blood/body fluids
229 Progesterone test reagents/kits Class B Progesterone test reagent/kit is a medical device intended for the estimation of Progesterone in blood/body fluids
230 Testosterone (Free and Total) test reagents/kits Class B Testosterone (Free and Total) test reagent/kit is a medical device intended for the estimation of Testosterone (Free and Total) in blood/body fluids
231 Sex Hormone Binding Globulin (SHBG) test reagents/kits Class B Sex Hormone Binding Globulin (SHBG) test reagent/kit is a medical device intended for the estimation of Sex Hormone Binding Globulin (SHBG) in blood/body fluids
232 Cortisol test reagents/kits Class B Cortisol test reagent/kit is a medical device intended for the estimation of Cortisol in blood/body fluids
233 Insulin test reagents/kits Class B Insulin test reagent/kit is a medical device intended for the estimation of Insulin in blood/body fluids
234 Luteinizing Hormone(LH) test reagents/kits Class B Luteinizing Hormones (LH) test reagent/kit is a medical device intended for the estimation of Luteinizing Hormone (LH) in blood/body fluids
235 Follicle Stimulating Hormone(FSH) test reagents/kits Class B Follicle Stimulating Hormone (FSH) test reagent/kit is a medical device intended for the estimation of Follicle Stimulating Hormone (FSH) in blood/body fluids
236 Prolactin test reagents/kits Class B Prolactin test reagent/kit is a medical device intended for the estimation of Prolactin in blood/body fluids
237 Other test reagents/kits for hormones Class B Test reagents/kits for the estimation of other than above hormones in blood/body fluids
238 Vitamin B test reagents/kits Class B Vitamin B test reagent/kit is a medical device intended for the estimation of Vitamin B in blood/body fluids
239 Vitamin D test reagents/kits Class B Vitamin D test reagent/kit is a medical device intended for the estimation of Vitamin B in blood/body fluids
240 Vitamin A test reagents/kits Class B Vitamin A test reagent/kit is a medical device intended for the estimation of Vitamin A in blood/body fluids
241 Vitamin E test reagents/kits Class B Vitamin E test reagent/kit is a medical device intended for the estimation of Vitamin E in blood/body fluids
242 Vitamin K test reagents/kits Class B Vitamin K test reagent/kit is a medical device intended for the estimation of Vitamin K in blood/body fluids
243 Other test reagents/kits for vitamins Class B Test reagents/kits for the estimation of other than above vitamins in blood/body fluids
244 Homocystein test reagents/kits Class B Homocystein test reagent/kit is a medical device intended for the estimation of Homocystein in blood/body fluids
245 allergens test reagents/kits Class B Test reagents/kits intended for the estimation of allergens in blood/body fluids
246 calibrators/co ntrols for above all in vitro diagnostic medical devices Calibrators Calibrators intended to be used with a reagent should be treated in the same class as the In vitro diagnostic medical device reagent.
247 Controls Controls intended to be used with a reagent should be treated in the same class as the In vitro diagnostic medical device reagent

Note: Anticoagulant Solutions, Embolization Particles, chitosan scaffold (for cartilage repair), Riboflavin (for Corneal Collagen cross-linking), silicone oil endotamponade, Intraocular Gases and Injectable Fillers shall be regulated as drugs under the provisions of the Drugs and Cosmetics Act, and Drugs and Cosmetics Rules, 1945.

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