Australia TGA ARTG record

Interpretive software IVDs

Australia TGA ARTG Registered Device · Siemens Healthcare Pty Ltd · Siemens Healthcare Diagnostics Products Ltd · Class IIb · Started March 29, 2018

Good Name: Siemens Healthcare Pty Ltd - Interpretive software IVDs

Device classification

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

Registration information

Start Date: March 29, 2018
Effective Date: March 29, 2018

Sponsor

Name: Siemens Healthcare Pty Ltd

Manufacturer

Name: Siemens Healthcare Diagnostics Products Ltd
Country: United Kingdom
Address: Glyn Rhonwy, Llanberis, Gwynedd, LL55 4EL

Intended purpose

Prenatal risk calculation software intended to assess foetal risk of congenital defects in first and second trimester screening.

About this record

Access comprehensive regulatory information for Interpretive software IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Siemens Healthcare Pty Ltd, manufactured by Siemens Healthcare Diagnostics Products Ltd in United Kingdom. The device registration started on March 29, 2018.

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.