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U.S. FDA Medical Device Drying Unit 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 Drying Unit companies with:

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