Australia TGA ARTG record

Software IVDs

Australia TGA ARTG Registered Device · Thermo Fisher Scientific Australia Pty Ltd · Trek Diagnostic Systems Ltd · Class I · Started July 10, 2020

Good Name: Thermo Fisher Scientific Australia Pty Ltd - Software IVDs

Device classification

Risk Class: Class I
Product Type: IVD
ARTG Category: IVD

Registration information

Start Date: July 10, 2020
Effective Date: July 10, 2020

Sponsor

Name: Thermo Fisher Scientific Australia Pty Ltd

Manufacturer

Name: Trek Diagnostic Systems Ltd
Country: United Kingdom
Address: Units 17 - 19 Birches Industrial Estate, East Grinstead, United Kingdom, RH19 1XZ

Intended purpose

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

About this record

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.