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U.S. FDA Medical Device Radiographic-Film Illuminator Requirements


FDA Medical Device Definition: A radiographic film illuminator is a device containing a visible light source covered with a translucent front that is intended to be used to view medical radiographs.

Registrar Corp assists Radiographic-Film Illuminator companies with:

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