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Dialysis system anticoagulation solution - ARTG 466385

Access comprehensive regulatory information for Dialysis system anticoagulation solution in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 466385 and sponsored by Paincare Technologies, manufactured by MediPac GmbH in Germany. The device registration started on October 30, 2024.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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Class IIb
ARTG 466385
Class IIb
Dialysis system anticoagulation solution
ARTG ID: 466385
Good Name: Paincare Technologies - Dialysis system anticoagulation solution
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Intended Purpose

Anticoagulant for blood. Natrium Citricum 3.13% (Sodium Citricum 3.13%) dilution for prevention of blood clotting in ozone therapy, HOT- and UVB autohemotherapy. For safe and effective catheter blocking in dialysis. Prevention of blood clotting for diagnostics purposes, including in-vitro-diagnostic. Packaged in 10ml ampoules and 100ml vials. GMDN number:45815, GMDN description: Hemodialysis citrate anticoagulation solution.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
466385
Start Date
October 30, 2024
Effective Date
October 30, 2024
Manufacturer
Country
Germany
Address
Eduard Rhein Str 1-3, Koenigswinter, 53639