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Dialysate, haemodialysis - ARTG 341610

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 registered under ARTG number 341610 and sponsored by Nipro Australia Pty Ltd, manufactured by Inspramed Medikal Sanayi ve Ticaret AS in Turkey. The device registration started on August 17, 2020.

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
ARTG 341610
Class IIb
Dialysate, haemodialysis
ARTG ID: 341610
Good Name: Nipro Australia Pty Ltd - Dialysate, haemodialysis
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Intended Purpose

Insprasol Haemodialysis Acid Concentrate is used for haemodialysis treatment by diluting suitably with basic bicarbonate concentrate and purified water. Diluted haemodialysis solution is used for replacing of electrolytes with toxic and liquid materials in blood via dialyser (semi-permeable membrane) without direct contact with blood. By this way, the electrolyte balance is provided.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
341610
Start Date
August 17, 2020
Effective Date
August 17, 2020
Manufacturer
Country
Turkey
Address
Serest Bolge 8 Cad No 29 Melikgazi, Kayseri, Turkiye, 38070