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U.S. FDA Medical Device Bedpan 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 Bedpan companies with:

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