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U.S. FDA Medical Device Amniotome Requirements

FDA Medical Device Definition: An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance.

Registrar Corp assists Amniotome companies with:

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