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U.S. FDA Medical Device Exophthalmometer Requirements

FDA Medical Device Definition: An exophthalmometer is a device, such as a ruler, gauge, or caliper, intended to measure the degree of exophthalmos (abnormal protrusion of the eyeball).

Registrar Corp assists Exophthalmometer companies with:

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