CDSCO risk classification
Urology medical device classification
Every urology device in CDSCO's classification register, with its risk class under the Medical Devices Rules, 2017 and its intended use. 24 are Class A non-sterile, non-measuring devices, which are exempt from licensing but must be registered.
- Devices
- 136
- Class A
- 32
- Class B
- 80
- Class C
- 18
- Class D
- 2
Urology devices and their class
136 devices
Artificial Urinary Sphincters implants
Urology
Class CIt is used to prevent incontinence by occluding the urethra.
Bare-metal urethral stent, short-term
Urology
Class CA sterile non-bioabsorbable tubular device intended to be placed short-term (<= 30 days) in the urethra to facilitate urethral patency and an unimpeded flow of urine from the bladder it is typically used to relieve lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).
Biliary/urinary stone retrieval basket
Urology
Class BA flexible manual instrument designed to remove biliary and/or urinary stones (gallbladder and/or renal calculi) from the body during an endoscopic procedure.
Bladder neck spreader
Urology
Class AA manual gastroenterology-urology surgical instrument with specially designed moveable blades intended to be used to separate and spread the bladder neck. This is a reusable device.
Bladder neck spreader, reusable
Urology
Class ANon-sterile, non-measuringA manual gastroenterology-urology surgical instrument intended to be used to manually separate and spread the bladder neck. This is a reusable device intended for transient use.
Bladder-emptying vibratory stimulator
Urology
Class BA battery-powered, hand-held device intended to be used in the home or healthcare facility by a patient to help initiate urination and facilitate complete bladder emptying through application of small mechanical vibrations to the lower abdomen to promote urethral sphincter relaxation.
Closed-ended wearable urine collection bag, non- sterile
Urology
Class not statedA non-sterile flexible plastic pouch designed to connect to a urinary catheter and to be strapped to the leg of a patient to collect discharged urine; it is not designed with an opening for urine drainage.
The class is missing from CDSCO's register data for this entry. Check the CDSCO register before relying on it.
Closed-ended wearable urine collection bag, sterile
Urology
Class not statedA sterile flexible plastic pouch designed to connect to a urinary catheter and to be strapped to the leg of a patient to collect discharged urine; it is not designed with an opening for urine drainage.
The class is missing from CDSCO's register data for this entry. Check the CDSCO register before relying on it.
Coude Catheters
Urology
Class BIt i s a urinary catheter, It may be used to inject liquids used for treatment or diagnosis of bladder conditions.
Cystometer
Urology
Class BA device used to examine the bladder, providing measurement data concerning pressure and volume. This data will be used for diagnostic evaluation of the neuromuscular mechanisms of the bladder.
Cystometer probe, ultrasonic
Urology
Class BA device that emits ultrasound energy generated by a cystometer in order to study bladder function by measuring bladder capacity, sensation, pressure, and residual urine.
Cystoscopic electrode
Urology
Class BA sterile electrical conductor intended to be placed in contact with the bladder to stimulate it and/or record its electrical activity for diagnostic examination.
Diaphragm wearable urinal
Urology
Class ANon-sterile, non-measuringA non-sterile urine drainage device designed for men with incontinence consisting of a front piece with a scrotal support and a leak-proof, flexible diaphragm through which the penis passes into a closed cone- shaped tube connected to a leg bag into which the urine is collected.
Double lumen Female Urethrographic Catheter
Urology
Class BIntended for vascular access infusion and withdrawal of blood, blood products, and fluids, plasmapheresis, Urethrographic hyperalimentation, central venous blood sampling and continuous and intermittent drag infusion.
Double Pigtail Ureteral Stent
Urology
Class CThis is a sterile, single-use, non-active, implantable device used for temporary internal drainage from the ureteropelvic junction to the bladder. The device is not intended to remain indwelling more than twelve months.
Draping incontinence liner
Urology
Class ANon-sterile, non-measuringA non-sterile padded sheet intended to cover and protect a device/piece of furniture (e.g., wheelchair, bed, sofa) occupied by an incontinent person by catching and retaining urine.
Drip wearable urinal
Urology
Class ANon-sterile, non-measuringA non-sterile urine drainage device designed for men to contain a moderate leakage consisting of a front piece with an integrated tubular sheath that fits fully over the penis and into which dribbling urine is collected.
Electrohydraulic lithotripsy system
Urology
Class BAn assembly of devices that uses plasma-induced shock waves for the intracorporeal fragmentation of stones (calculi) found in the kidney, ureter, and bladder.
Electrohydraulic/pneumatic lithotripsy system probe, urinary, single-use
Urology
Class BA sterile, slender, rod-like device intended to be used as part of an intracorporeal lithotripsy system to transmit shock waves from electrohydraulic or pneumatic sources directly to a calculus in the urinary tract (i.e., kidneys, ureters, and bladder), providing high-speed fragmentation of the calculus in situ.
Electromechanical lithotripsy system, extracorporeal
Urology
Class BAn assembly of devices that non-invasively disintegrates stones (i.e., calculi) by sending focused shock waves from outside the body produced by an electromechanical generator.
Electromechanical lithotripsy system, intracorporeal
Urology
Class BAn assembly of devices designed to create shock waves through electromechanical action for the intracorporeal fragmentation of calculi (stones) in the urinary tract (i.e., kidney, ureter and bladder) the resulting debris may be actively removed or passed out by natural means at a later date.
Endoscope Bridge/Adaptor
Urology
Class ANon-sterile, non-measuringA non-powered, non-invasive accessory of a rigid or flexible endoscope assembly intended to provide access to an endoscope (e.g., cystoscope, hysteroscope, etc.) and other endoscopic elements and enable their assembly to create a complete operative endoscopic unit. It may contain ports to enable the insertion of instruments (through the endoscope or independent working channels) for their simultaneous operation (e.g., suction, irrigation, etc.). This is a non-sterile, reusable device.
Female wearable urinal, reusable
Urology
Class ANon-sterile, non-measuringA non-sterile, urine drainage device designed for women that typically consists of a flexible tube attached to a collector that is specially formed to securely fit around the female genitals to provide a route to channel urine, via a tube, into a collection bag.
Fibreoptic ureteral catheter, reusable
Urology
Class BA flexible tube containing a fibreoptic bundle that emits light throughout its length, intended to be inserted into the ureter for illumination to enable the path of the ureter to be seen. It also includes a plug for connection to a fibreoptic light source and a port for irrigation at its proximal end.
Filiform urethral bougie
Urology
Class BAn extremely thin, wire-like, manual surgical instrument designed for traversing and exploring urethral strictures and/or dilating the urethra, introduced directly or through an appropriately- threaded urethral catheter.
Flexible endoscopic stone- retrieval forceps, reusable
Urology
Class BA flexible manual device intended to be inserted through the working channel of a compatible flexible endoscope to grasp and remove stones (e.g., calculi from the urinary tract) or foreign bodies during an endoscopic procedure.
Flexible fibreoptic cystonephroscope
Urology
Class BAn endoscope with a flexible inserted portion intended for the visual examination/treatment of the bladder, the urethra (including the prostate region), and the kidneys.
Flexible fibreoptic cystoscope
Urology
Class BAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urinary tract.
Flexible fibreoptic cystourethroscope
Urology
Class BAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urethra, including the prostate region.
Flexible fibreoptic nephroscope
Urology
Class BAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the kidney. It is inserted percutaneously into the renal pelvis during nephroscopy.
Flexible fibreoptic ureterorenoscope
Urology
Class BAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter and the renal pelvis.
Flexible fibreoptic ureteroscope
Urology
Class BAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter (the upper urinary tract that connects the kidney to the bladder).
Flexible fibreoptic urethroscope
Urology
Class BAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the urethra (the muscular tube that leaves the urinary bladder for the excretion of urine).
Flexible ureteral sheath/fibreoptic telescope
Urology
Class BA sterile device assembly intended to function as a flexible endoscope for the visual examination and treatment of body cavities/organs that can be accessed via the ureter for cystoscopic, nephroscopic, laparoscopic, and ureteroscopic procedures.
Flexible video cystonephroscope
Urology
Class BAn endoscope with a flexible inserted portion intended for the visual examination/treatment of the bladder, urethra (including prostate region), and kidneys.
Flexible video cystoscope, reusable
Urology
Class BAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urinary tract by introduction through the urethra.
Flexible video cystourethroscope
Urology
Class BAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urethra, including the prostate region.
Flexible video nephroscope
Urology
Class BAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the kidney.
Flexible video ureterorenoscope, reusable
Urology
Class BAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter and the renal pelvis.
Flexible video ureteroscope, reusable
Urology
Class BAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter (the upper urinary tract that connects the kidney to the bladder).
Flexible video urethroscope
Urology
Class BAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the urethra (the muscular tube that leaves the urinary bladder for the excretion of urine).
Forceps, kidney, reusable
Urology
Class ANon-sterile, non-measuringA manual, scissors-like surgical instrument intended to grasp, manipulate or support the kidney. This is a reusable device intended for sterilization prior to use.
General-purpose ureteral catheter
Urology
Class BA flexible tube designed for introduction into the ureters through a cystoscope or nephroscope.
Hand pneumatic lithotripsy system, urinary
Urology
Class BAn assembly of devices, held by the operator, that uses pneumatically-created ballistic shock waves for the intracorporeal fragmentation of stones (calculi) in the urinary tract (i.e., kidneys, ureters, and bladder) for their removal.
Hand-held urinal, female
Urology
Class AA portable, hand-held container/set, typically made of plastic, intended to be directly urinated into by a female (typically bed-bound) patient for excretory purposes.
Hand-held urinal, female, reusable
Urology
Class ANon-sterile, non-measuringIntended as a container/set to be directly urinated into by a female (typically bed-bound) patient for excretory purposes. This is a reusable device.
Hand-held urinal, male, reusable
Urology
Class ANon-sterile, non-measuringA portable, hand-held container intended to be directly urinated into by a male (typically bed-bound) patient for excretory purposes.
Hepatic function analysis system
Urology
Class BAn assembly of mains electricity (AC-powered) devices intended to aid in the quantitative assessment of liver function by the in vivo measurement of the plasma concentration and clearance of a tracer substance [e.g., indocyanine green (ICG)] in the peripheral vasculature following intravenous injection.
Home faecal specimen collection kit
Urology
Class AA collection of non-sterile devices and materials intended to be used by a layperson to collect and mail a faecal (stool) sample to a clinical laboratory for diagnostic testing or screening purposes (e.g. occult blood, cytology).
Hydraulic male urinary incontinence treatment system
Urology
Class CAn assembly of implantable devices intended to treat male urinary incontinence by applying pressure to partially/fully occlude the bladder neck and/or urethra, typically after radical prostatectomy or transurethral resection of the prostate.
Hydraulic male urinary incontinence treatment system port
Urology
Class CAn implantable component of a hydraulic male urinary incontinence treatment system intended to provide access to the system’s inflatable pad (e.g., cushion, balloon), for the intra- and/or postoperative introduction/removal of fluid (e.g., saline).
Hydraulic male urinary incontinence treatment system tubing
Urology
Class CAn implantable length of tube that functions as a component of a hydraulic male urinary incontinence treatment system and intended to provide connection between the system’s inflatable pad (e.g., cushion, balloon) and the system’s port, for the intra- and/or postoperative introduction/removal of fluid (e.g., saline) it is typically made of silicone and metal.
Hydraulic male urinary incontinence treatment system tubing plug
Urology
Class CAn implantable component of a hydraulic male urinary incontinence treatment system intended to seal the system’s tubing to prevent spillage/leakage of its contents when introduction/removal of fluid to/from the system’s pad (e.g., cushion, balloon) is not needed it is typically made of metal.
Implanted mechanical/hydraulic urinary continence device
Urology
Class CAn 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.
Incontinence device suspender
Urology
Class ANon-sterile, non-measuringA device used by a person with a disability to secure a body-worn incontinence device [e.g., a nappy (diaper) or a pad] in a stable and safe position.
Incontinence penis clamp, reusable
Urology
Class ANon-sterile, non-measuringA male urinary incontinence device designed to gently compress the penis, either the proximal shaft or the glans penis, to occlude the urethra and prevent involuntary urination/dribbling for men who are incontinent of the bladder.
Incontinence sensor/alarm
Urology
Class BAn electrically-powered electronic device intended to provide an audible, visible and/or tactile signal to alert the patient or a caregiver when a small quantity of urine and/or faeces incontinently released is detected by a sensing mechanism (e.g., a sensor pad or detector).
Inflatable penile prosthesis
Urology
Class CAn inflatable/deflatable sterile device designed of several interconnected components intended to be surgically implanted in a patient with erectile dysfunction (ED) [commonly known as impotence] in order to achieve selective penile tumescence and rigidity adequate for vaginal intercourse.
Injectable implant for the treatment of vesicoureteral reflux
Urology
Class CTreatment of vesicoureteral reflux.
Intermittent urethral catheterization kit, non-sterile
Urology
Class BA collection of non-sterile devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for self-urinary catheterization.
Intermittent urethral catheterization kit, sterile
Urology
Class BA collection of sterile devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for self-urinary catheterization.
Intermittent urethral drainage catheter, antimicrobial
Urology
Class BA sterile, flexible or rigid, tube designed to be repeatedly inserted through the urethra, typically by the user (i.e., self-applied), to the urinary bladder to provide short-term, episodic urine drainage (removed after each void), typically for an individual who is physiologically incapable of voiding.
Intermittent urethral drainage catheter, non- sterile
Urology
Class BA non-sterile, flexible or rigid, tube designed to be repeatedly inserted through the urethra, typically by the user (i.e., self-applied), to the urinary bladder to provide short-term, episodic urine drainage (removed after each void), typically for an individual who is physiologically incapable of voiding.
Intermittent urethral drainage catheter, sterile
Urology
Class BA sterile, flexible or rigid, tube designed to be repeatedly inserted through the urethra, typically by the user (i.e., self-applied), to the urinary bladder to provide short-term, episodic urine drainage (removed after each void), typically for an individual who is physiologically incapable of voiding.
Internal Urethrotomy Sheath
Urology
Class BA non-powered accessory of an endoscope intended to facilitate the insertion and guidance of an endoscope and other endoscopic surgical instruments into the urethra during visual internal urethrotomy (VIU) procedure. This may be a reusable/single-use device.
Intracorporeal lithotripsy suction system
Urology
Class BAn assembly of devices designed for use with an intracorporeal lithotripsy system to evacuate, by suction, the irrigation fluid-containing fragments of urinary calculi from the kidneys, ureters, and bladder during lithotripsy.
Intraurethral valve/pump
Urology
Class BA sterile, non-powered device intended to be inserted into the female urethra to facilitate urine voiding in patients with incomplete bladder emptying due to impaired detrus or contractility (IDC) of neurologic origin.
Irrigation Bulb
Urology
Class AA hand-held, sterile device intended to manually instill and aspirate sterile irrigation fluid through a compatible urological catheter [not included] or tract to irrigate, flush, or assess the patency of the urinary tract or an established urological tract during diagnostic or therapeutic procedures. This is a single-use device.
Laser lithotripsy fibre/suction guide
Urology
Class CA sterile device intended to be inserted through the working channel of a rigid nephroscope during laser lithotripsy 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), 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.
Laser lithotripsy system
Urology
Class CAn assembly of devices consisting of a specialized ureteroscope, a laser resistant catheter, and a dedicated laser designed for the intracorporeal disintegration of ureteral stones (calculi).
Lithotrite
Urology
Class BA hand-held manual surgical instrument designed for the mechanical crushing of renal stones (calculi) in the urinary tract and/or bladder.
Male External Wearable Incontinence Catheter
Urology
Class ANon-sterile, non-measuringA non-sterile, externally-worn (non-invasive) urine-drainage device intended to be worn over the penis of an incontinent male patient to channel urine to a collection bag [not included] or bedside incontinence management system [not included]. This is not intended to store/retain urine. This is a single-use device.
Male urinary outflow analysis system
Urology
Class BA mains electricity (AC-powered) assembly of devices intended to be used to measure urine flow rate and to estimate iso-volumetric bladder pressure in men with the use of an inflatable penile cuff. It typically consists of a dedicated computer and application software, an automatic cuff inflation/deflation unit, a single-use penile cuff, and a load-measuring cell/stand.
Male urinary outflow analysis system cuff
Urology
Class BA non-sterile inflatable cuff that is a component of a male urinary outflow analysis system.
Manometric catheter sheath
Urology
Class BA non-sterile, synthetic polymer sleeve intended to cover/protect and prevent contamination of a manometric catheter (including barostat catheter).
Microwave hyperthermia system catheter, prostatic- ablation, reusable
Urology
Class CA thin rod intended to be used as part of a hyperthermia system to treat disorders of the prostate [e.g., cancer, benign prostatic hyperplasia (BPH), prostatitis] through the local application of heat from microwaves.
Multiple-piece urostomy bag, non-sterile
Urology
Class ANon-sterile, non-measuringThe urostomy bag, composed of two or more parts, is intended to attach to a patient's skin around a stoma for use as a urinary collection device in the management of urinary diversions. This is a single-patient use device.
Nephrostomy Tract Dilator, single-use
Urology
Class BA set of sterile, non-powered dilators intended for progressively dilating the nephrostomy tract during percutaneous nephrostomy procedures and maintaining the tract opening once established to allow passage of surgical instrumentation. This is a short-term, single-use device.
One-piece urostomy bag, non-sterile
Urology
Class ANon-sterile, non-measuringThe ostomy bag is intended to collect output from a stoma. The adhesive is intended to fix the bag and adhere to intact skin around the stoma.
One-piece urostomy bag, open-ended, non-sterile
Urology
Class not statedA one-piece plastic pouch intended to be attached to a patients skin around a stoma for use as a urine collection device in the management of urinary diversions; it includes a drainage tap to permit the emptying of fluids (open-ended).
The class is missing from CDSCO's register data for this entry. Check the CDSCO register before relying on it.
Ostomy Bag Cover/Protector
Urology
Class ANon-sterile, non-measuringA non-sterile, externally applied protective cover intended for use by individuals with a surgically-created colostomy, ileostomy, or urostomy, to provide temporary protection to the ostomy bag and surrounding area from water exposure during bathing or showering. It may also be used to protect an ostomy bag from harmful external influences (e.g., puncture, etc.). This is not a stoma shield.
Pelvic floor exerciser, male
Urology
Class ANon-sterile, non-measuringA manual, non-powered, non-sterile device intended to provide assistance for pelvic floor muscle exercises to adult males suffering from Intravaginal ejaculation disorders, such as premature ejaculation, etc.
Penile extracorporeal shock wave therapy system
Urology
Class BA mobile assembly of devices designed to provide spark-gap-generated, low-intensity, extracorporeal shock wave therapy to treat erectile dysfunction (ED) [impotence] to rehabilitate penile erection and rigidity adequate for intercourse.
Penile extracorporeal shock wave therapy system applicator
Urology
Class BA hand-held device designed to transmit spark-gap- generated (electrohydraulic), low-intensity, shock waves from a penile extracorporeal shock wave therapy system generator to the skin of the penile shaft and the penile crura to treat erectile dysfunction (ED) [impotence] to rehabilitate penile erection and rigidity adequate for intercourse.
Penile inflatable implant
Urology
Class DA 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.
Penile rigidity implant
Urology
Class CA 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.
Penis wearable urinal
Urology
Class BA non-sterile, externally-worn, urine drainage device intended to be worn over the penis of an incontinent male patient to channel urine, via a tube, into a collection bag. It consists of a urinary incontinence penis attachment (e.g., sheath or adhesive port), tubing, and a wearable urine collection bag.
Penis/scrotum wearable urinal
Urology
Class BA non-sterile urine drainage device designed for men with incontinence and a retracted penis that includes a front piece (a shaped cone) intended to contain both the penis and the scrotum to form a leak-proof seal around the male genitals.
Perineal orifice incontinence-control electrical stimulation system, remote control
Urology
Class CAn assembly of battery-powered, remote-controlled devices designed for intravaginal pelvic floor exercise to treat urinary incontinence and other pelvic problems in women (e.g., pelvic pain and sexual dysfunction) through the application of electrical stimuli to the muscles of the pelvic floor.
Piezoelectric lithotripsy system
Urology
Class CAn assembly of devices that non-invasively disintegrates stones (i.e., calculi) by sending focused shock waves from outside the body produced by a piezoelectric generator.
Protective garment for Incontinence
Urology
Class ANon-sterile, non-measuringA specially-designed device Intended to collect an incontinent patients urine and excreta. It is not a diaper intended for children.
Pyeloscope
Urology
Class BAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the renal pelvis and major or minor calyces.
Retention Type Balloon Catheter
Urology
Class BIt 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.
Retention Type Catheter
Urology
Class BThis type of catheter is placed into the bladder and secured there for a period of time.
Rigid cystoscope
Urology
Class BAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the bladder and the urinary tract.
Rigid cystourethroscope
Urology
Class BAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the bladder and the urethra, including the prostate region.
Rigid nephroscope
Urology
Class BAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the kidney.
Rigid ureterorenoscope
Urology
Class BAn endoscope with a rigid or semi-rigid inserted portion intended for the visual examination and treatment of the ureter and the renal pelvis some types may have a flexible tip at the distal end of the inserted portion.
Rigid ureteroscope
Urology
Class BAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the ureter, (the upper urinary tract that connects the kidney to the bladder).
Rigid urethroscope
Urology
Class BAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the urethra (the muscular tube that leaves the urinary bladder for the excretion of urine).
Rigid video ureterorenoscope
Urology
Class not statedA sterile endoscope with a rigid or semi-rigid inserted portion intended for the visual examination and treatment of the ureter and the renal pelvis; some types may have a flexible tip at the distal end of the inserted portion.
The class is missing from CDSCO's register data for this entry. Check the CDSCO register before relying on it.
Spark-gap lithotripsy system
Urology
Class BAn assembly of devices that non-invasively disintegrates stones (i.e., calculi) by sending focused shock waves from outside the body produced by a spark-gap generator.
Straight Catheter
Urology
Class BIt is used in patients with neurogenic bladder or spinal cord injury, lessens the risk of urinary tract infection.
Suprapubic Catheter
Urology
Class BA suprapubic catheter is a thin, sterile tube used to drain urine from bladder.
Suprapubic Catheterization Kit, short-term use
Urology
Class BA collection of non-powered, sterile devices intended to facilitate percutaneous placement of a urinary drainage catheter (short-term use, non-implantable) into the bladder through a suprapubic incision to enable urine drainage. This includes a Suprapubic catheter (non-implantable urinary drainage catheter), trocar and scalpel blade. This may also include other non-powered accessories such as connectors, catheter holder, and stop cock, etc. This is a short-term use (<30 days), single-use device.
Suprapubic needle, surgical, reusable
Urology
Class BA hand-held manual surgical instrument designed with a sharp pyramidal or conical point at the distal end to percutaneously puncture the lower abdominal wall to provide suprapubic access for surgical repair, typically to position a sling used in the treatment of female stress urinary incontinence (SUI) associated with bladder prolapse.
Suprapubic, non-disposable Cannula
Urology
Class BAn emergency measure for the relief of acute urinary retention or condition which require temporary and permanent drainage of bladder.
Temperature-monitoring indwelling urethral drainage catheter
Urology
Class BA sterile, flexible tube with an inflatable balloon on its distal tip for retention in the urinary bladder, after its insertion through the urethra, where it functions as a long-term indwelling device for continuous urinary drainage and simultaneous monitoring of core body temperature through its integral temperature sensor, typically during or after surgery or in the presence of obstruction or paralysis.
Testicular prosthesis
Urology
Class DA 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.
Testicular temperature regulation underpants
Urology
Class ANon-sterile, non-measuringA garment that is intended to be body worn around the pelvic region to keep the testicles cool for increased spermatogenesis, as part of an fertility treatment, through ventilation features (e.g., breathable mesh) that prevent excessive insulation of the testes. This is not an active device.
Transobturator needle, reusable
Urology
Class BA hand-held manual surgical instrument with a sharp pyramidal or conical point used to create a percutaneous puncture using the transobturator approach (i.e., the insertion points overlie the obturator space in the genitofemoral crease lateral to the vagina), for the surgical positioning of a sling used in the treatment of stress urinary incontinence (SUI), which may be associated with a prolapse.
Transvaginal needle, surgical
Urology
Class BA hand-held manual surgical instrument with a sharp pyramidal or conical point designed to create a puncture in the vaginal wall for the surgical positioning of a sling typically used in the treatment of stress urinary incontinence (SUI) associated with bladder prolapse.
TUR Irrigation Tubing Set, single-use
Urology
Class BA collection of tubing and associated non-powered accessories intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline, etc.) from its source (e.g., gravity feed bag, feed pump - not included) to a laparoscope channel [not included] during transurethral resection of the prostate (TURP) to remove blood, debris and other particles from the surgical field and enable clear field of view. It typically has a port for connecting to a laparoscope for continuous irrigation. It is not intended to administer drugs or nutrition to the body. This is a single-use device.
Ultrasonic lithotripsy system
Urology
Class BAn assembly of devices designed to use ultrasonic (US) shock waves for the intracorporeal fragmentation of stones (calculi) found in the kidney, ureter, and bladder.
Upper Urinary Tract Catheter
Urology
Class BThe catheter to the bladder and subsequently to the upper urinary tract.
Ureteral patency kit
Urology
Class BA collection of devices intended to assist treatment of a blocked ureter and to help maintain ureteral patency through natural orifice or percutaneous access.
Ureteral stent
Urology
Class CIndicated 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.
Urethral Catheter/Nelaton Catheter/Foley Catheter
Urology
Class BA long, small gauge catheter designed for insertion directly into a ureter, either through the urethra and bladder or posteriorly via the kidney.
Urethral drainage catheter punch
Urology
Class BA hand-held manual instrument designed for cutting a small hole (e.g., 0.3 mm diameter) into the distal end of a closed Foley catheter (usually 14.0 French or larger) to form a "Council tip Foley catheter", allowing it to be placed over a guidewire or ureteral catheter.
Urethral/suprapubic catheter valve-connector
Urology
Class AA small, sterile valve intended to be connected to a urethral and/or suprapubic catheter to allow intermittent bladder drainage/filling (as an alternative to continuous drainage).
Urethrographic Male Catheter
Urology
Class BA catheter used to pass into a man's bladder.
Urinary dilator, reusable
Urology
Class ANon-sterile, non-measuringIntended to dilate the urinary duct. This is a reusable device. This is not intended for long- term use and not connected to an active device.
Urinary Drainage Unit
Urology
Class BA closed urinary drainage system consists of a catheter inserted into the urinary bladder and connected via tubing to a drainage bag.
Urinary-incontinence vaginal insert, reusable
Urology
Class ANon-sterile, non-measuringA non-sterile, device intended to be inserted into the vagina in order to relieve mixed or stress urinary incontinence in an adult female by providing urethral support when pressure is transferred from the abdomen to the pelvic floor area (e.g. upon coughing, laughing, sneezing, exertion).
Urine Collection Bag, non-wearable
Urology
Class AA sterile, external device intended to collect urine through a urinary catheter [not included]. It may have attached tubing and graduation marks for urine output. This is a single-use device.
Urine Collection Bag, sterile, measuring
Urology
Class AA sterile, open-ended bag with a measuring chamber/bottle, intended for use in conjunction with a urine collection system [not included], for the collection, temporary storage and accurate measurement of urine output in bedridden, critically ill or postoperative patients. It is not a patient-wearable device. This is a single-use device.
Urine Collection System
Urology
Class AAn assembly of non-invasive devices intended to be used by an incontinent/bed-bound patient for the removal of urine. It typically consists of a vacuum pump, collection canister, and tubings (urinals/catheters not included). It can be used to monitor urine output.
Urodynamic measurement system
Urology
Class BAn assembly of devices used for advanced diagnosis/study of the bladder. It is used to identify the cause of abnormal voiding, including incontinence and is useful for the diagnosis of, e.g., neurogenic bladder diseases, stress incontinence, urinary path obstruction or spastic sphincters.
Urological Endoscope Obturator
Urology
Class BA hand-held, manual device intended for use in connection with an endoscope (e.g., resectoscope) to assist its insertion into the body and protect against damage to the patient during the Transurethral resection of the prostate (TURP). This is a reusable device intended to be sterilized prior to use.
Urological Lithotripter Bridge
Urology
Class BA non-powered, specially-designed endoscope accessory intended to connect an endoscope (e.g., cystoscope/resectoscope)/endoscope sheath with a pneumatic lithotripter during endoscopic urological procedures (such as transurethral resection of the prostate (TURP), etc.). This may be a reusable/single-use device.
Urological operating table top
Urology
Class ANon-sterile, non-measuringA component of a modular operating table intended for use as a detachable table top to support a patient during urological examination and surgical procedures, including cystoscopic procedures and both transurethral and open surgery of the urinary tract.
Urological operating table, electrohydraulic
Urology
Class ANon-sterile, non-measuringA mobile, mains electricity (AC-powered) hydraulic-mechanism table intended to support a patient during urological examination and surgical procedures, including cystoscopic procedures and both transurethral and open surgery of the urinary tract. This does not have a measuring function.
Urological operating table, electromechanical
Urology
Class ANon-sterile, non-measuringA mobile, electrically-powered motorized table intended to support a patient during urological examination and surgical procedures, including cystoscopic procedures and both transurethral and open surgery of the urinary tract. This does not have a measuring function.
Urological operating table, hydraulic/Transurethral resection table
Urology
Class ANon-sterile, non-measuringA mobile table powered by manually-operated hydraulic mechanisms intended to support a patient during urological examination and surgical procedures, including cystoscopic procedures and both transurethral and open surgery of the urinary tract. This does not have a measuring function.
Urological Stone Retrieval/Extraction Set, mechanical
Urology
Class BA collection of manual, endoscopic surgical instruments, including a stone-retrieval forceps/mechanical lithotrite, sheaths, obturator, etc., intended for mechanical fragmentation and extraction of urinary bladder stones during endoscopic urological procedures. It may include channels for irrigation/suction. This is a reusable device.
Urological TURP Set, electrosurgical
Urology
Class CA collection of endoscopic instruments, including electrosurgical resection electrodes, an endoscope (e.g., resectoscope), obturators, bridge, endoscope sheath and connectors, and other accessories such as tubing, stopcock, etc., intended for use in Transurethral Resection of the Prostate (TURP) procedure for resection of obstructing prostate tissue, thereby relieving urinary symptoms and improving the flow of urine for patients with benign prostatic hyperplasia (BPH). This may be a reusable/single-use device.
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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