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U.S. FDA Medical Device Perineal Binder Requirements

FDA Medical Device Definition: A therapeutic medical binder is a device, usually made of cloth, that is intended for medical purposes and that can be secured by ties so that it supports the underlying part of the body or holds a dressing in place. This generic type of device includes the abdominal binder, breast binder, and perineal binder.

Registrar Corp assists Perineal Binder companies with:

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