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U.S. FDA Medical Device Electrode Cable Requirements

FDA Medical Device Definition: An electrode cable is a device composed of strands of insulated electrical conductors laid together around a central core and intended for medical purposes to connect an electrode from a patient to a diagnostic machine.

Registrar Corp assists Electrode Cable companies with:

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