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Clinical chemistry enzyme IVDs - ARTG 480910

Access comprehensive regulatory information for Clinical chemistry enzyme IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 480910 and sponsored by Thermo Fisher Scientific Australia Pty Ltd, manufactured by Sentinel CH SpA in Italy. The device registration started on February 26, 2025.

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 IIa
ARTG 480910
Class IIa
Clinical chemistry enzyme IVDs
ARTG ID: 480910
Good Name: Thermo Fisher Scientific Australia Pty Ltd - Clinical chemistry enzyme IVDs
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Intended Purpose

IVDs that are intended to be used for the qualitative and/or quantitative determination of Angiotensin converting enzyme (ACE) activity in human serum or plasma.

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
480910
Start Date
February 26, 2025
Effective Date
February 26, 2025
Manufacturer
Country
Italy
Address
Via Robert Koch 2, Milan, 20152