Profile: Coloplast A/S develops products and services that make life easier for people with very personal & private medical conditions. Our business includes ostomy care, urology & continence care, and wound & skin care. Our SpeediCath family is a new generation of safe, hygienic catheters that offer ease of use, greater comfort and minimal risk of urethral micro-trauma for all catheter users. Our SpeediCath Compact is the first catheter made to suit the anatomy of the female body. It has the same low-friction coating as our other SpeediCath products. This unique coating makes catheterisation more comfortable and reduces the risk of urethral micro-trauma even if self-catheterisation is done for a lifetime. SenSura is our latest range of ostomy bags. They have a unique double-layer adhesive that makes them secure, comfortable to wear and very easy to use. Our SenSura Xpro offers extra protection against aggressive output. It is suitable for people with an ostomy that has a more aggressive output which breaks down normal adhesives too quickly. The SenSura Xpro adhesives are available in both flat and convex light versions.

The company was founded in 1957, has revenues of USD 100-500 Million, has ~7000 employees and is CE certified. CSE:CLPT2 (SEC Filings)

FDA Registration Number: 9610694
US Agent: Kimberly Tokach / Coloplast Corp.
Phone: +1-(612)-344-2440  E-Mail:

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• Sterile Urethral Catheterization Kit (FDA Code: FCM / 876.5130) A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudecatheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

• Stomal Bag (FDA Code: GDS / 876.5900) An ostomy pouch and accessories is a device that consists of a bag that is attached to the patient's skin by an adhesive material and that is intended for use as a receptacle for collection of fecal material or urine following an ileostomy, colostomy, or ureterostomy (a surgically created opening of the small intestine, large intestine, or the ureter on the surface of the body). This generic type of device and its accessories includes the ostomy pouch, ostomy adhesive, the disposable colostomy appliance, ostomy collector, colostomy pouch, urinary ileostomy bag, urine collecting ureterostomy bag, ostomy drainage bag with adhesive, stomal bag, ostomy protector, and the ostomy size selector, but excludes ostomy pouches which incorporate arsenic-containing compounds.

• Straight Catheter (FDA Code: EZD / 876.5130)

• Surgical Urethral Catheter (FDA Code: GBM / 876.5130)

• Testicle Prosthesis (FDA Code: FAF / 876.3750) A testicular prosthesis is an implanted device that consists of a solid or gel-filled silicone rubber prosthesis that is implanted surgically to resemble a testicle.

• Tieman Coude Catheters

• Universal Dressing

• Ureteral Catheter Holder (FDA Code: EYJ / 876.5130)

• Ureteral Splint (FDA Code: FAD / 876.4620) A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.

• Urethral Catheters (FDA Code: GBM / 876.5130)

• Urinary Collection Bag

• Urine Collection Leg Bags (FDA Code: FAQ / 876.5250) A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection. The two kinds of urine collectors are:

• Urine Collector and Accessories (FDA Code: KNX / 876.5250)

• Urine Leg Bags (FDA Code: FAQ / 876.5250)

• Urological Catheter Care Kits

• Urological Catheters (FDA Code: KOD / 876.5130)

• Urological Catheters, Intermittent Catheters

• Urosheath Type Incontinence Appliance (FDA Code: EXJ / 876.5250)

• Vaginal Mold (FDA Code: HFK / 884.3900) A vaginal stent is a device used to enlarge the vagina by stretching, or to support the vagina and to hold a skin graft after reconstructive surgery.

• Vaginal Pessary (FDA Code: HHW / 884.3575) A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia.

• Water Jet Lavage Unit (FDA Code: FQH / 880.5475) A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.

• Wound Exudate Absorption Hydrophilic Beads (FDA Code: KOZ / 878.4018) A hydrophilic wound dressing is a sterile or non-sterile device intended to cover a wound and to absorb exudate. It consists of nonresorbable materials with hydrophilic properties that are capable of absorbing exudate (e.g., cotton, cotton derivatives, alginates, dextran, and rayon). This classification does not include a hydrophilic wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.