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U.S. FDA Medical Device Closed Urine Drainage System Requirements


FDA Medical Device Definition: 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:(1) A urine collector and accessories intended to be connected to an indwelling catheter, which includes the urinary drainage collection kit and the closed urine drainage system and drainage bag; and (2) A urine collector and accessories not intended to be connected to an indwelling catheter, which includes the corrugated rubber sheath, pediatric urine collector, leg bag for external use, urosheath type incontinence device, and the paste-on device for incontinence.

Registrar Corp assists Closed Urine Drainage System companies with:

  • FDA Closed Urine Drainage System Establishment Registration
  • FDA Closed Urine Drainage System Listing
  • FDA Closed Urine Drainage System Label Requirements and Exceptions
  • FDA Closed Urine Drainage System Import Information
  • FDA Closed Urine Drainage System Detentions (Closed Urine Drainage System Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Closed Urine Drainage System Manufacturers (Closed Urine Drainage System Suppliers)
       - Closed Urine Drainage System Distributors
       - Closed Urine Drainage System Processors
       - Closed Urine Drainage System Repackers
       - Closed Urine Drainage System Relabelers
       - Closed Urine Drainage System Exporters
       - Closed Urine Drainage System Importers
For more information about Closed Urine Drainage System Medical Devices, simply click below:






 
U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.


Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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