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U.S. FDA Medical Device Heat-Sealing Device Requirements


FDA Medical Device Definition: A heat-sealing device is a device intended for medical purposes that uses heat to seal plastic bags containing blood or blood components.

Registrar Corp assists Heat-Sealing Device companies with:

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