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Software IVDs

Access comprehensive regulatory information for Software IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Thermo Fisher Scientific Australia Pty Ltd, manufactured by Trek Diagnostic Systems Ltd in United Kingdom. The device registration started on July 10, 2020.

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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TGA ARTG Official Data
Class I
Class I
Software IVDs
Australia TGA ARTG Registered Device
Good Name: Thermo Fisher Scientific Australia Pty Ltd - Software IVDs
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Intended Purpose

Software that is intended to be used with an IVD to determine characteristics of microorganisms including bacteria and yeasts

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
July 10, 2020
Effective Date
July 10, 2020
Manufacturer
Country
United Kingdom
Address
Units 17 - 19 Birches Industrial Estate, East Grinstead, United Kingdom, RH19 1XZ