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U.S. FDA Medical Device Dialyzer 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 Dialyzer companies with:

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