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U.S. FDA Medical Device Freezer Requirements


FDA Medical Device Definition: General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.

Registrar Corp assists Freezer companies with:

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