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:

Deletion of S.N. 333 i.e. Sterile
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

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

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.

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

Ablation Device

Percutaneous Conduction Tissue Ablation

Class D

Clinical applications using hollow needles (cryoprobes) through which cooled, thermally conductive, fluids are circulated.

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.

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.

Ablation Device

RF Conducte MR steerable electrode catheter

Class C

It is intended for intracardiac ablation.

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.

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.

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.

Cardiac Stents

Bifurcation Stent

Class C

Intended for improving the side branch luminal diameter of arterial bifurcation liaisons.

Catheters

Fiberoptic Oximeter Catheter

Class B

Intended for monitoring the balance between oxygen delivery and consumption at the bedside

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.

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.

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.

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

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.

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.

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

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.

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.

Catheters

Tracheobronchial Suction Catheter

Class B

Clearing the airways of mucus, pus, or aspirated materials to improve oxygenation and ventilation.

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

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.

Catheters

Balloon for Cerebrovascular Occlusion

Class D

Balloon used to treat Blockage or closing of Cerebrovascular vessels/carotid arteries

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

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

Catheters

Tracheostomy Tube/Tracheal Tube

Class B

A breathing tube inserted into a tracheotomyused to obtain a closed circuit for ventilation

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.

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.

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.

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.

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.

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.

Catheters

Suction Tip and Catheter

Class B

Suction Catheters feature a whistle tip and a thumb control port for precise and accurate suctioning.

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.

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.

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.

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.

Catheters

Bartholin Gland Catheter

Class B

Catheter is used for the treatmenti of abscesses and cysts of the Hartholin gland.

Catheters

Bronchography Catheter

Class B

Intended to deliver therapeutic and diagnostic agents that are indicated or labeled for airway, tracheal or

Catheters

Cholangiography Catheter

Class B

Diagnostic evaluation of the bile ducts during laparoscopic cholecystectomy procedures

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

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

Catheters

Continuous Flush Catheter

Class B

Intended for the controlled and selective infusion of

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.

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.

Catheters

Depezzer Catheter

Class B

A tubular, flexible instrument, passed through body channels for withdrawal o f fluids from a body cavity.

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.

Catheters

Epidural Catheter

Class B

Epidural catheter is a very thin, flexible tube that is implanted into spine

Catheters

Esophageal Balloon Catheter

Class B

intended for use in adult and adolescent populations

Catheters

Eustachian Catheter

Class B

It is used to test Eustachian tube patency

Catheters

Guiding Catheter

Class B

The guide catheter provides support for device advancement .

Catheters

Haemodialysis Catheter

Class B

A catheter used for exchanging blood to and from the haemodialysis machine from the patient.

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.

Catheters

Intramuscular Pressure Monitoring Catheter

Class B

A modified fibre optic transducer- tipped catheter system for measuring intramuscular pressures during exercise was determined.

Catheters

Introducer Sheath

Class C

Intended to provide easier access to the femoral, popliteal and infrapopliteal arteries.

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

Catheters

Jejunostomy Catheter

Class B

Used for intraoperative feeding jejunostomy

Catheters

Multiple Lumen Catheter

Class B

Intended for monitoring central venous pressure (CVP), sampling blood, and simultaneou administratio of multiple IV solutions or drugs

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.

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.

Catheters

Carotid Filter System

Class C

Used while performing angioplasty and stenting procedures in carotid arteries.

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.

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.

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.

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

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.

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.

Catheters

Retention Type Catheter

Class B

This type of catheter is placed into the bladder and secured there for a period of time.

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

Catheters

Salpngography Catheter

Class B

Used for injection of contrast medium
into the fallopian tube(s) for selective salpingography.

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

Catheters

Straight Catheter

Class B

It is used in patients with neurogenic bladder or spinal cord injury, lessens the risk of urinary tract infection

Catheters

Subclavian Catheter

Class B

Catheters can be placed in veins in the neck (internal jugular vein), chest (subclavian vein or auxiliary vein),

Catheters

Suprapubic Catheter

Class B

A suprapubic catheter is a thin, sterile tube used to drain urine from bladder.

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

Catheters

Upper Urinary Tract Catheter

Class B

The catheter to the bladder and subsequently to the upper urinary tract

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.

Catheters

Urethrographic Male Catheter

Class B

A catheter used to pass into a man’s bladder.

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.

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)

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.

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

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;

Catheters

Percutaneous Long Term Intraspinal Catheter

Class C

To conduct a preimplantintra spinal infusion screening trial procedure prior to implanting a pump

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

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

Catheters

Peripheral, Transluminal Angioplasty Catheter

Class C

A catheter for treating peripheral vascular diseases

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.

Catheters

Cardiovascular Catheter

Class D

A thin, hollow tube called a catheter is inserted into a large blood vessel that leads to heart.

Catheters

Cerebrospinal Catheter

Class D

For treatment or prevention of cranial/spinal cerebrospinal fluid fistula.

Catheters

Atherectomy Coronary Catheter

Class D

A catheter containing a rotating cutter and a collecting chamber for debris, used for atherectomy and endarterectomy.

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.

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

Catheters

Embolectomy Catheter

Class D

indicated for the removal of fresh, soft emboli and

Catheters

Flow Directed Catheter

Class B

Used for venous sampling and pressure monitoring.

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

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