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Troponin IVDs - ARTG 460225

Access comprehensive regulatory information for Troponin IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 460225 and sponsored by Siemens Healthcare Pty Ltd, manufactured by Sero AS in Norway. The device registration started on August 21, 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.

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Class IIb
ARTG 460225
Class IIb
Troponin IVDs
ARTG ID: 460225
Good Name: Siemens Healthcare Pty Ltd - Troponin IVDs
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Intended Purpose

The QC material is intended to be used as a quality control material for the Siemens Atellica VTLi system for cardiac Troponin I.

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
460225
Start Date
August 21, 2024
Effective Date
August 21, 2024
Manufacturer
Country
Norway
Address
Stasjonsveien 44, Billingstad, N-1396