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Haemodialysis dialysate delivery system, multi-patient

Australia TGA ARTG Registered Device · Fresenius Medical Care Australia Pty Ltd · Fresenius Medical Care AG · Class IIa · Started September 29, 2021

Good Name: Fresenius Medical Care Australia Pty Ltd - Haemodialysis dialysate delivery system, multi-patient

Device classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration information
Start Date
September 29, 2021
Effective Date
September 29, 2021
Sponsor
Manufacturer
Country
Germany
Address
Else-Kroner-Str 1, Bad Homburg, 61352
Intended purpose

The CDS3 (concentrate delivery system) is a device for the delivery of acid concentrates from storage tanks. The fluids are transported from storage tanks via a ring main system. Dialysis devices use the acid concentrates to prepare the dialysates. Two storage tanks per concentrate can be connected. These are monitored by internal or external sensors for detecting an empty tank and are controlled by the CDS3. The CDS3 is operated in the immediate vicinity of the concentrate containers outside the treatment room.

About this record

Access comprehensive regulatory information for Haemodialysis dialysate delivery system, multi-patient in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Fresenius Medical Care Australia Pty Ltd, manufactured by Fresenius Medical Care AG in Germany. The device registration started on September 29, 2021.

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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