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U.S. FDA Medical Device Maddox Lens Requirements

FDA Medical Device Definition: A Maddox lens is a device that is a series of red cylinders that change the size, shape, and color of an image. The device is intended to be handheld or placed in a trial frame to evaluate eye muscle dysfunction.

Registrar Corp assists Maddox Lens companies with:

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