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U.S. FDA Medical Device Non-Illuminated Speculum Requirements


FDA Medical Device Definition: A speculum is a device intended to be inserted into a body cavity to aid observation. It is either nonilluminated or illuminated and may have various accessories.

Registrar Corp assists Non-Illuminated Speculum companies with:

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