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U.S. FDA Medical Device Urinal Requirements

FDA Medical Device Definition: A body waste receptacle is a device intended for medical purposes that is not attached to the body and that is used to collect the body wastes of a bed patient

Registrar Corp assists Urinal companies with:

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