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U.S. FDA Medical Device Diagnostic Condensing Lens Requirements


FDA Medical Device Definition: A diagnostic condensing lens is a device used in binocular indirect ophthalmoscopy (a procedure that produces an inverted or reversed direct magnified image of the eye) intended to focus reflected light from the fundus of the eye.

Registrar Corp assists Diagnostic Condensing Lens companies with:

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