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U.S. FDA Medical Device Pupillograph Requirements


FDA Medical Device Definition: A pupillograph is an AC-powered device intended to measure the pupil of the eye by reflected light and record the responses of the pupil.

Registrar Corp assists Pupillograph companies with:

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