Pure Global

Dialysate, haemodialysis - ARTG 404490

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 404490 and sponsored by Vitramed Pty Ltd, manufactured by Inspramed Medikal Sanayi ve Ticaret AS in Turkey. The device registration started on February 08, 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIb
ARTG 404490
Class IIb
Dialysate, haemodialysis
ARTG ID: 404490
Good Name: Vitramed Pty Ltd - Dialysate, haemodialysis
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

Inspracart Haemodialysis Sodium Bicarbonate Cartridge is used by diluting suitably with acidic bicarbonate concentrate and purified water. Diluted haemodialysis solution is supplied in haemodialysis device plunging of toxic and leakage materials in blood to replace the lacking electrolytes by dialyzer (semi-permeable membrane) without direct contact with blood.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
404490
Start Date
February 08, 2023
Effective Date
February 08, 2023
Sponsor
Manufacturer
Country
Turkey
Address
Serest Bolge 8 Cad No 29 Melikgazi, Kayseri, Turkiye, 38070