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U.S. FDA Medical Device Chilling Unit Requirements

FDA Medical Device Definition: A chilling unit is a refrigerative device intended for medical purposes to chill and maintain cold packs at a reduced temperature.

Registrar Corp assists Chilling Unit companies with:

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