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U.S. FDA Medical Device Examination Light Requirements

FDA Medical Device Definition: A battery-powered medical examination light is a battery-powered device intended for medical purposes that is used to illuminate body surfaces and cavities during a medical examination.

Registrar Corp assists Examination Light companies with:

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