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U.S. FDA Medical Device Hyaluronidase Requirements

FDA Medical Device Definition: Enzyme preparations are products that are used in the histopathology laboratory for the following purposes:

Registrar Corp assists Hyaluronidase companies with:

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