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U.S. FDA Medical Device Crimp Ring Requirements


FDA Medical Device Definition: A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.

Registrar Corp assists Crimp Ring companies with:

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