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U.S. FDA Medical Device Dialysis Tie Requirements

FDA Medical Device Definition: A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.

Registrar Corp assists Dialysis Tie companies with:

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