Australia TGA ARTG record

General laboratoryware IVDs

Australia TGA ARTG Registered Device · Southern Cross Diagnostics Pty Ltd · Orgentec Diagnostika GmbH · Class I · Started April 08, 2024

Good Name: Southern Cross Diagnostics Pty Ltd - General laboratoryware IVDs

Device classification

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

Registration information

Start Date: April 08, 2024
Effective Date: April 08, 2024

Sponsor

Name: Southern Cross Diagnostics Pty Ltd

Manufacturer

Name: Orgentec Diagnostika GmbH
Country: Germany
Address: Carl-Zeiss-Strasse 49-51, Mainz, 55129

Intended purpose

General reagents and consumables intended by the manufacturer to be used by pathology laboratories in manual, semi-automated or automated clinical chemistry IVD procedures.

About this record

Access comprehensive regulatory information for General laboratoryware IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Southern Cross Diagnostics Pty Ltd, manufactured by Orgentec Diagnostika GmbH in Germany. The device registration started on April 08, 2024.

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.