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U.S. FDA Medical Device ENT Syringe Requirements

FDA Medical Device Definition: An ear, nose, and throat drug administration device is one of a group of ear, nose, and throat devices intended specifically to administer medicinal substances to treat ear, nose, and throat disorders. These instruments include the powder blower, dropper, ear wick, manual nebulizer pump, and nasal inhaler.

Registrar Corp assists ENT Syringe companies with:

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