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U.S. FDA Medical Device Ophthalmic Refractometer Requirements


FDA Medical Device Definition: An ophthalmic refractometer is an automatic AC-powered device that consists of a fixation system, a measurement and recording system, and an alignment system intended to measure the refractive power of the eye by measuring light reflexes from the retina.

Registrar Corp assists Ophthalmic Refractometer companies with:

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