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U.S. FDA Medical Device Breathing Mouthpiece Requirements

FDA Medical Device Definition: A breathing mouthpiece is a rigid device that is inserted into a patient's mouth and that connects with diagnostic or therapeutic respiratory devices.

Registrar Corp assists Breathing Mouthpiece companies with:

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