Australia TGA ARTG record

Software IVDs

Australia TGA ARTG Registered Device · Roche Diagnostics Australia Pty Limited · Hamilton Bonaduz AG · Class I · Started May 06, 2024

Good Name: Roche Diagnostics Australia Pty Limited - Software IVDs

Device classification

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

Registration information

Start Date: May 06, 2024
Effective Date: May 06, 2024

Sponsor

Name: Roche Diagnostics Australia Pty Limited

Manufacturer

Name: Hamilton Bonaduz AG
Country: Switzerland
Address: Via Crusch 8, Bonaduz, 7402

Intended purpose

Software that is supplied separately intended to operate or influence an IVD instrument/analyser

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 Roche Diagnostics Australia Pty Limited, manufactured by Hamilton Bonaduz AG in Switzerland. The device registration started on May 06, 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.