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U.S. FDA Medical Device Urine Collector & Accessories 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 are1) 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 Urine Collector & Accessories companies with:

  • FDA Urine Collector & Accessories Establishment Registration
  • FDA Urine Collector & Accessories Listing
  • FDA Urine Collector & Accessories Label Requirements and Exceptions
  • FDA Urine Collector & Accessories Import Information
  • FDA Urine Collector & Accessories Detentions (Urine Collector & Accessories Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Urine Collector & Accessories Manufacturers (Urine Collector & Accessories Suppliers)
       - Urine Collector & Accessories Distributors
       - Urine Collector & Accessories Processors
       - Urine Collector & Accessories Repackers
       - Urine Collector & Accessories Relabelers
       - Urine Collector & Accessories Exporters
       - Urine Collector & Accessories Importers
For more information about Urine Collector & Accessories 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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