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U.S. FDA Medical Device Emesis Basin 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 Emesis Basin companies with:

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