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Interpretive software IVDs - ARTG 301421

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 registered under ARTG number 301421 and 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.

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Class IIb
ARTG 301421
Class IIb
Interpretive software IVDs
ARTG ID: 301421
Good Name: Siemens Healthcare Pty Ltd - Interpretive software IVDs
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Intended Purpose

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

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
301421
Start Date
March 29, 2018
Effective Date
March 29, 2018
Manufacturer
Country
United Kingdom
Address
Glyn Rhonwy, Llanberis, Gwynedd, LL55 4EL