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U.S. FDA Medical Device Fornixscope Requirements

FDA Medical Device Definition: A fornixscope is a device intended to pull back and hold open the eyelid to aid examination of the conjunctiva.

Registrar Corp assists Fornixscope companies with:

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