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U.S. FDA Medical Device 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 Illuminated Speculum companies with:

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