Australia flagARTG 301420

Clinical chemistry hormone IVDs

ARTG ID: 301420 · Siemens Healthcare Pty Ltd · Siemens Healthcare Diagnostics Products Ltd · Class IIb · Started March 29, 2018

Good Name: Siemens Healthcare Pty Ltd - Clinical chemistry hormone IVDs

Device classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration information
ARTG ID
301420
Start Date
March 29, 2018
Effective Date
March 29, 2018
Sponsor
Manufacturer
Country
United Kingdom
Address
Glyn Rhonwy, Llanberis, Gwynedd, LL55 4EL
Intended purpose

For in vitro diagnostic use as maternal screening assays to aid in the detection of neural tube defects, Down syndrome and other chromosomal anomalies.

About this record

Access comprehensive regulatory information for Clinical chemistry hormone IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 301420 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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