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NxStage PureFlow SL - Dialysate delivery system, haemodialysis, single patient

Access comprehensive regulatory information for NxStage PureFlow SL - Dialysate delivery system, haemodialysis, single patient 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 October 18, 2023.

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
Class IIb
NxStage PureFlow SL - Dialysate delivery system, haemodialysis, single patient
Australia TGA ARTG Registered Device
Good Name: Fresenius Medical Care Australia Pty Ltd - NxStage PureFlow SL - Dialysate delivery system, haemodialysis, single patient
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Intended Purpose

The NxStage PureFlow SL uses potable water to prepare dialysates for haemodialysis therapy and monitors and controls the delivery of the dialysate to the NxStage heamodialysis cycler.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
October 18, 2023
Effective Date
October 18, 2023
Manufacturer
Country
United States of America
Address
350 Merrimack Street, Lawrence, MA, 01843