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U.S. FDA Medical Device Medical Examination Device Requirements


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

Registrar Corp assists Medical Examination Device companies with:

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