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U.S. FDA Medical Device Manual Pupillometer Requirements

FDA Medical Device Definition: A pupillometer is an AC-powered or manual device intended to measure by reflected light the width or diameter of the pupil of the eye.

Registrar Corp assists Manual Pupillometer companies with:

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