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U.S. FDA Medical Device Compression Dressing Requirements

FDA Medical Device Definition: An elastic bandage is a device consisting of either a long flat strip or a tube of elasticized material that is used to support and compress a part of a patient's body.

Registrar Corp assists Compression Dressing companies with:

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