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U.S. FDA Medical Device Micro Mixer 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 Micro Mixer companies with:

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