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U.S. FDA Medical Device Water Purifier Requirements

FDA Medical Device Definition: A medical ultraviolet water purifier is a device intended for medical purposes that is used to destroy bacteria in water by exposure to ultraviolet radiation.

Registrar Corp assists Water Purifier companies with:

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