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U.S. FDA Medical Device Manual Refractor Requirements

FDA Medical Device Definition: A manual refractor is a device that is a set of lenses of varous dioptric powers intended to measure the refractive error of the eye.

Registrar Corp assists Manual Refractor companies with:

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