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U.S. FDA Medical Device Battery-Powered Retinoscope Requirements


FDA Medical Device Definition: A retinoscope is an AC-powered or battery-powered device intended to measure the refraction of the eye by illuminating the retina and noting the direction of movement of the light on the retinal surface and of the refraction by the eye of the emergent rays.

Registrar Corp assists Battery-Powered Retinoscope companies with:

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