CDSCO risk classification
Nephrology and Renal Care medical device classification
Every nephrology and renal care device in CDSCO's classification register, with its risk class under the Medical Devices Rules, 2017 and its intended use. 4 are Class A non-sterile, non-measuring devices, which are exempt from licensing but must be registered.
- Devices
- 65
- Class A
- 6
- Class B
- 31
- Class C
- 26
- Class D
- 2
Nephrology and Renal Care devices and their class
65 devices
A-V Shunt Cannula
Nephrology and Renal Care
Class CIt is inserted into one of the client's blood vessels to facilitate repeated hemodialysis.
A-V Shunt or Fistula Adapter
Nephrology and Renal Care
Class BA blood access device and accessories is a device intended to provide access to a patients blood for haemodialysis or other chronic uses.
Absorbable peritoneum catheter cuff
Nephrology and Renal Care
Class DIntended to maintain stable contact between the skin and the peritoneal dialysis catheter, and prevents bacterial invasion from the outlet. It is embedded subcutaneously at the outlet of the peritoneal dialysis catheter.
Anticoagulant catheter/cannula flush solution
Nephrology and Renal Care
Class CA solution containing a low dose of an anticoagulant agent(s) (e.g., heparin, trisodium citrate, etc.) in a syringe or a container for flushing the lumen of an intravenous access device (e.g., peripheral intravenous cannula or central venous catheter) to prevent clot formation and maintain patency. This may also be referred to as a lock solution. This does not contain antimicrobial agents
Arteriovenous Fistula Cannulation Guide
Nephrology and Renal Care
Class CAn implantable device intended to be attached/sutured around an arteriovenous fistula (AVF) under the skin to function as a vascular access guide to facilitate repeatable needle access via the buttonhole cannulation method during haemodialysis procedures. This is a permanent implant intended for single-patient use. This is not an implantable catheter.
Automated peritoneal dialysis system
Nephrology and Renal Care
Class CAn active medical devices intended to perform peritoneal dialysis.
Chair, Haemodialysis, Electrically powered/Manual.
Nephrology and Renal Care
Class AIntended to support the patient in a seated or reclined posture during haemodialysis procedures.
Citric acid haemodialysis system cleaning cartridge
Nephrology and Renal Care
Class BIntended for the in-line preparation of a citric acid solution to clean/disinfect the fluid pathways of the system (remove calcium and magnesium deposits) in combination with a heat disinfection program.
Collagen-containing peritoneum absorbable catheter cuff
Nephrology and Renal Care
Class DA cuff that consists of biodegradable porous material containing collagen, intended to be embedded subcutaneously at the outlet of the peritoneal dialysis catheter.
Crimp for plier, Haemodialysis
Nephrology and Renal Care
Class AIntended to manipulate the arteriovenous shunt of patients required hemodialysis.
Dialysate Tubing and Connector
Nephrology and Renal Care
Class BA tubing connector adapted for peritoneal dialysis connections between tubing sets and containers of dialysate.
Dialyser connector
Nephrology and Renal Care
Class BIntended to connect between a dialysis fluid circuit and dialyzer, etc.
Dialysis apheresis unit, Therapeutic
Nephrology and Renal Care
Class CIntended to filtrates the blood and separates the plasma, and extracts specific substances in the plasma (e.g., LDL-cholesterol). Then, the plasma is passed through the filtration column in the device and the specific substances that are combined with various substrates are extracted.
Dialysis bag clamp/clip
Nephrology and Renal Care
Class ANon-sterile, non-measuringIntended to be used for opening or closing the dialysis tube.
Dialysis Machine
Nephrology and Renal Care
Class CIt is used for acute or chronic kidney failure that filters blood to remove excess water and waste products.
Dialysis set holder
Nephrology and Renal Care
Class ANon-sterile, non-measuringIntended to hold and secure in position a dedicated set being used during a dialysis procedure.
Disposable Hemoperfusion Cartridge
Nephrology and Renal Care
Class CIntended in hemoperfusion machine to thoroughly remove the endogenous and exogenous materials such as residual drugs, toxins and metabolic substances in patients by means of adsorption of synthetic resin and extracorporeal blood circulation.
Electrical conductivity measuring instrument for dialysis fluid
Nephrology and Renal Care
Class CIntended to determine the concentration of dialysis fluid supplied to a dialyzer based on the measurement of electrical conductivity of dialysis fluid (usually it is electrically measured)
Extracorporeal circuit waste bag
Nephrology and Renal Care
Class BIntended to be used for the collection of waste fluids during preparation and processing of an extracorporeal circuit (e.g., haemodialysis, haemofiltration, apheresis, adsorption treatment), including the collection and rinsing of ultrafiltrate fluid which may contain blood components.
Fistula Needle
Nephrology and Renal Care
Class BTo connect blood lines with the blood vessels through needles when dialysis is carried out.
Flexible fibreoptic nephroscope
Nephrology and Renal Care
Class BIntended for the visual examination of internal structures and treatment of the kidney (eg: renal calcus) by inserting percutaneously into the renal pelvis during nephroscopy.
Forceps, stone removal/Open-surgery stone-retrieval forceps, reusable
Nephrology and Renal Care
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to grasp and/or manipulate a calculus (i.e., a kidney or gallbladder stone) during an open surgical procedure additional intended uses may include soft-tissue manipulation (e.g., polyp removal). This is a transient-use, reusable device intended to be sterilized prior to use. it is not intended for laparoscopic/endoscopic use.
Haemodialysis Catheter
Nephrology and Renal Care
Class BA catheter used for exchanging blood to and from the haemodialysis machine from the patient.
Haemodialysis Catheterization Kit
Nephrology and Renal Care
Class BA collection of non-powered, sterile devices intended for gaining temporary or short-term vascular access during hemodialysis for the exchange of blood to and from the hemodialysis machine and the patient. This may include a haemodialysis catheter (non-implantable), introducer needle, guidewire, scalpel, vessel dilator, disposable syringe, adhesive bandage and other non-powered accessories intended for temporary use. This is a single-use device.
Haemodialysis chair, electrically powered/Manual
Nephrology and Renal Care
Class ANon-sterile, non-measuringIntended to support the patient in a seated or reclined posture during haemodialysis procedures.
Haemodialysis Concentrate
Nephrology and Renal Care
Class CIntended to remove metabolic waste from the blood to help maintain physiological blood electrolyte and pH levels while haemodialysis is performed
Haemodialysis conductivity standard solution
Nephrology and Renal Care
Class CIntended to calibrate conductivity meters used to test the conductivity of dialysate, dialysate concentrate, and water treatment systems used with haemodialysis delivery systems.
Haemodialysis dialysate water chlorine test kit/strip
Nephrology and Renal Care
Class BIntended to be used to rapidly indicate, through colour change, the concentration of total chlorine in water used to prepare dialysate solution for haemodialysis.
Haemodialysis system air/foam detector
Nephrology and Renal Care
Class CIntended to identify air bubbles and/or foam in blood returned to the body [usually through an arteriovenous fistula (AVF)] by the extracorporeal blood circuit of a haemodialysis system.
Haemodialysis system central monitor
Nephrology and Renal Care
Class CDevice intended to connect with multiple haemodialysis systems in order to aid monitoring several dialysis treatments simultaneously.
Haemodialysis system plasma filtration unit
Nephrology and Renal Care
Class CAn electrically-powered integral unit of a haemodialysis system that allows for the removal of plasma from the blood and the infusion of an equal amount of plasma replacement solution to the blood.
Haemodialyzer reprocessing system
Nephrology and Renal Care
Class CIntended to clean (incl. rinsing, cleaning, testing and record keeping of process) and disinfect haemodialysis dialyzers after each use so that they can be reused.
Haemofilters
Nephrology and Renal Care
Class CA filter used in the process of haemofiltration, to allow for the removal of toxins and/or the replacement of electrolytes.
Hemodiafiltration system
Nephrology and Renal Care
Class CA device used for blood purification with a hemodiafilter.
Hemodialysis blood tubing/Extracorporeal systems for blood purification
Nephrology and Renal Care
Class BSterilized blood tubing intended for hemodialysis (including hemofiltration and hemodiafiltration).
Hemodialysis Cannula
Nephrology and Renal Care
Class BAllowing 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.
Hemodialysis Catheter
Nephrology and Renal Care
Class BA catheter used for exchanging blood to and from the haemodialysis machine from the patient.
Hemodialysis Catheter (Long Term)
Nephrology and Renal Care
Class CA 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
Hemodialysis system bicarbonate mixer
Nephrology and Renal Care
Class CIntended to mixes two concentrates, A and B, plus water, to the dialysis solution (dialysate) and monitors the mixture.
Hemodialysis system transducer protector
Nephrology and Renal Care
Class BA device intended for use with haemodialysis blood lines to protect a haemodialysis system pressure monitor from contamination and to help maintain the sterility of the blood tubing fluid pathway, by preventing transfer of viruses, bacteria, and particulate matter, and preventing the flow of fluids (blood, etc.) to the pressure monitor.
Hollow-fibre haemodialysis dialyser
Nephrology and Renal Care
Class CHollow fiber filter intended to remove impurities/fluid from the blood of a patient via haemodialysis machine.
Kidney donor-organ preservation/transport system
Nephrology and Renal Care
Class CA dedicated system designed to support and maintain a donated kidney organ during transport from the donor to the receiver hospital where the organ will be transplanted into the recipient.
Kidney stone filter
Nephrology and Renal Care
Class CA filter intended to be placed in the urinary duct to prevent a renal stone from moving from the kidney into the bladder.
Laser lithotripsy fibre/suction guide
Nephrology and Renal Care
Class BIntended to function as a channel for insertion of the laser fibre of a laser beam guide (e.g., of a general/multiple surgical laser system) in nephroscope, and for removal of debris (e.g., fluid, calculi fragments) when connected to a vacuum source.
CDSCO lists this name more than once with different classes. Match on the intended use and category.
Multi-patient dialysis fluid delivery system
Nephrology and Renal Care
Class CIntended to prepares dialysis fluid for hemodialysis using an artificial kidney, capable of supplying dialysis fluid for two or more patients.
Nephrostomy Catheter
Nephrology and Renal Care
Class BA nephrostomy is a tube that’s used to drain urine from a kidney into a bag outside the body.
Nephrostomy Catheterization Kit
Nephrology and Renal Care
Class BA collection of non-powered, sterile devices intended to facilitate percutaneous access to the renal pelvis to allow urine drainage from the kidneys to the outside of the body. This includes a Nephrostomy catheter (non-implantable urinary drainage catheter), puncture needle, guidewire, dilators, and scalpel. This may also include other non-powered accessories such as urine bag connectors, intravenous catheter holder, and stop cock, etc.
Nephrostomy Tube
Nephrology and Renal Care
Class BThe nephrostomy tube drains urine from kidney into a collecting bag outside the body.
Nephrostomy/Nephroscopy Sheath
Nephrology and Renal Care
Class BA non-powered instrument intended to and gain access and allow introduction of nephroscope/telescope and other surgical instruments in the upper urinary tract for performing endoscopic interventions.
Peritoneal Dialysis Catheter
Nephrology and Renal Care
Class BThat allows dialysis fluid to enter the abdominal cavity, dwell inside for a while, and then drain back out again
Peritoneal dialysis catheter adaptor
Nephrology and Renal Care
Class BIntended to connect (devices of different makers and makes devices compatible with each other) a catheter for peritoneal lavage to an external device that manages dialysates.
Peritoneal dialysis catheter guidewire
Nephrology and Renal Care
Class BA guidewire used temporarily for correction of the position of a peritoneal dialysis catheter.
Peritoneal dialysis dialysate warmer
Nephrology and Renal Care
Class CIntended to heat the dialysate to within on degree, of kidney patient who is on continuous ambulatory peritoneal dialysis (CAPD), body temperature prior to infusion.
Peritoneal dialysis system dialysate filter
Nephrology and Renal Care
Class CA microporous device used to capture contamination particles of the dialysate before its instillation into the peritoneal cavity.
Peritoneal Dialysis Transfer Set
Nephrology and Renal Care
Class BA transfer set is tubing that you use to connect your catheter to the bag of dialysis solution. It consists of tubing, connectors etc.
Peritoneal dialysis ultraviolet irradiation unit
Nephrology and Renal Care
Class Bintended for ultraviolet irradiation for disinfection of components of peritoneal dialysis transfer tube set.
Portable continuous peritoneal perfusate thermal conditioner
Nephrology and Renal Care
Class BA device that heats the peritoneal perfusate before injection into the peritoneal cavity. The perfusate is usually heated through direct contact of the dialysis fluid bag with the radiant heat source.
Reverse Osmosis Unit (for dialysis)
Nephrology and Renal Care
Class CIntended to be used with haemodialysis to produce water through reverse osmosis with quality suitable for use with haemodialysis equipment.
Rigid nephroscope
Nephrology and Renal Care
Class BIntended for visual examination, diagnosis, and treatment of the kidney, renal pelvis, major calyces, and minor calyces by percutaneously inserting scope into the renal pelvis.
Shunt thrombus suction set
Nephrology and Renal Care
Class BA set used to suction a thrombus developing inside an arteriovenous shunt (external shunt) during procedures including hemodialysis.
Single Needle Haemodialysis Catheter/Blood Lines
Nephrology and Renal Care
Class BThe single-needle dialysis, in which case only one cannula or a single-lumen catheter is used to access the blood.
Single Needle Hemodialysis Catheter/ Blood lines
Nephrology and Renal Care
Class BThe single-needle dialysis, in which case only one cannula or a single lumen catheter is used to access the blood.
Sodium carbonate haemodialysis system cleaning cartridge
Nephrology and Renal Care
Class CIntended to be connected to the fluid circuit of an institutional haemodialysis system for the in-line preparation of a sodium carbonate solution to clean the fluid pathways of the system (remove organic deposits, fats, proteins) in combination with a heat disinfection program.
Urinary stone retrieval basket
Nephrology and Renal Care
Class BIntended to remove urinary stones (renal calculi) from the body during an endoscopic procedure.
Water Jet Renal Catheter
Nephrology and Renal Care
Class BA device used to dislodge stones from renal calyces (recesses of the pelvis or the kidney) by means of a pressurized stream of water through a conduit.
Data from CDSCO's online system for medical devices, retrieved 2026-10-31.
Sources
- Risk Classification Approved Device Details, CDSCO online system for medical devices. Retrieved 31 October 2026.
- Merged existing medical devices risk classification, CDSCO public notice, 1 January 2025.
See the full source list and how the data is compiled on the main classification page. This is a reference aid, not legal or regulatory advice.
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