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Dialysate, haemodialysis

Access comprehensive regulatory information for Dialysate, haemodialysis in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Fresenius Medical Care Australia Pty Ltd, manufactured by NxStage Medical Inc in United States of America. The device registration started on February 01, 2011.

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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TGA ARTG Official Data
Class IIb
Class IIb
Dialysate, haemodialysis
Australia TGA ARTG Registered Device
Good Name: Fresenius Medical Care Australia Pty Ltd - Dialysate, haemodialysis
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Intended Purpose

A premixed solution used in dialysis treatment and which is prepared for the exchange of solutes across a semi-permeable membrane, to assist in the removal of toxic waste products without the loss of essential electrolytes and excessive water depletion.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
February 01, 2011
Effective Date
February 01, 2011
Manufacturer
Country
United States of America
Address
350 Merrimack Street, Lawrence, MA, 01843