Pure Global

Instrument/analyser IVDs - ARTG 175543

Access comprehensive regulatory information for Instrument/analyser IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 175543 and sponsored by Southern Cross Diagnostics Pty Ltd, manufactured by Orgentec Diagnostika GmbH in Germany. The device registration started on September 08, 2010.

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 I
ARTG 175543
Class I
Instrument/analyser IVDs
ARTG ID: 175543
Good Name: Southern Cross Diagnostics Pty Ltd - Instrument/analyser IVDs
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

Manual, semi-automated or automated equipment or apparatus that are intended by the manufacturer to be used as an in vitro diagnostic medical device (IVD) for the purposes of processing, examining and/or providing information about a clinical specimen.

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
175543
Start Date
September 08, 2010
Effective Date
September 08, 2010
Manufacturer
Country
Germany
Address
Carl-Zeiss-Strasse 49-51, Mainz, 55129