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U.S. FDA Medical Device Tonometer Sterilizer Requirements


FDA Medical Device Definition: A tonometer sterilizer is an AC-powered device intended to heat sterilize a tonometer (a device used to measure intraocular pressure).

Registrar Corp assists Tonometer Sterilizer companies with:

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