Australia TGA ARTG record

Software IVDs

Australia TGA ARTG Registered Device · Integrated Sciences Pty Ltd · AESKU.DIAGNOSTICS GmbH & Co. KG · Class I · Started July 19, 2024

Good Name: Integrated Sciences Pty Ltd - Software IVDs

Device classification

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

Registration information

Start Date: July 19, 2024
Effective Date: July 19, 2024

Sponsor

Name: Integrated Sciences Pty Ltd

Manufacturer

Name: AESKU.DIAGNOSTICS GmbH & Co. KG
Country: Germany
Address: Mikroforum Ring 2, Wendelsheim, 55234

Intended purpose

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.

About this record

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.