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U.S. FDA Medical Device Haidinger Brush Requirements

FDA Medical Device Definition: A Haidinger brush is an AC-powered device that provides two conical brushlike images with apexes touching which are viewed by the patient through a Nicol prism and intended to evaluate visual function. It may include a component for measuring macular integrity.

Registrar Corp assists Haidinger Brush companies with:

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