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U.S. FDA Medical Device Heparin Requirements

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

Registrar Corp assists Heparin companies with:

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