Australia TGA ARTG record

Inborn/inherited genetic disorder IVDs

Australia TGA ARTG Registered Device · Elitechgroup Australia Pty Ltd · ViennaLab Diagnostics GmbH · Class IIb · Started August 07, 2023

Good Name: Elitechgroup Australia Pty Ltd - Inborn/inherited genetic disorder IVDs

Device classification

Risk Class: Class IIb
Product Type: IVD
ARTG Category: IVD

Registration information

Start Date: August 07, 2023
Effective Date: August 07, 2023

Sponsor

Name: Elitechgroup Australia Pty Ltd

Manufacturer

Name: ViennaLab Diagnostics GmbH
Country: Austria
Address: 43-45 Gaudenzdorfer Guertel, Vienna, A-1120

Intended purpose

Devices intended to be used in screening/confirmation of congenital/inherited disorders.

About this record

Access comprehensive regulatory information for Inborn/inherited genetic disorder IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Elitechgroup Australia Pty Ltd, manufactured by ViennaLab Diagnostics GmbH in Austria. The device registration started on August 07, 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.