Software IVDs - ARTG 447050
Access comprehensive regulatory information for Software IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 447050 and sponsored by Roche Diagnostics Australia Pty Limited, manufactured by Roche Sequencing Solutions Inc in United States of America. The device registration started on April 29, 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.
Software that is supplied separately intended to operate or influence an IVD instrument/analyser

