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U.S. FDA Medical Device Colposcope Requirements: Colposcope

FDA Medical Device Definition: A colposcope is a device designed to permit direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose abnormalities and select areas for biopsy. This generic type of device may include a light source, cables, and component parts

Registrar Corp assists Colposcope companies with:

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

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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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