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U.S. FDA Medical Device Adhesive Tape & Bandage Requirements


FDA Medical Device Definition: A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin.

Registrar Corp assists Adhesive Tape & Bandage companies with:

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