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U.S. FDA Medical Device Urine Collection Bag Requirements

FDA Medical Device Definition: 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

Registrar Corp assists Urine Collection Bag companies with:

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