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U.S. FDA Medical Device Binocular Loupe Requirements

FDA Medical Device Definition: A low-power binocular loupe is a device that consists of two eyepieces, each with a lens or lens system, intended for medical purposes to magnify the appearance of objects.

Registrar Corp assists Binocular Loupe companies with:

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