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U.S. FDA Medical Device Ophthalmic Lens Gauge Requirements


FDA Medical Device Definition: An ophthalmic lens gauge is a calibrated device intended to manually measure the curvature of a spectacle lens.

Registrar Corp assists Ophthalmic Lens Gauge companies with:

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