Software IVDs
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 sponsored by Integrated Sciences Pty Ltd, manufactured by AESKU.DIAGNOSTICS GmbH & Co. KG in Germany. The device registration started on July 19, 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.
HERA is a web-based software (Data Management System) and can be considered an IVD device, when used in combination with specific IVD equipment and IVD software (LIS). It is a scalable connectivity solution that can handle connectivity to multiple instruments,multiple LISs, multiple users and multiple sites. It is designed to handle the clinical laboratory automation workflow, from dispatching specimens, to verifying results and generating internal reports.