Software IVDs - ARTG 384577
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 384577 and sponsored by Diagnostic Technology Pty Ltd, manufactured by Hamilton Bonaduz AG in Switzerland. The device registration started on February 23, 2022.
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 intended to be incorporated into an IVD instrument to supplement operational functions including the processing of clinical specimens

