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Instrument/analyser IVDs

Access comprehensive regulatory information for Instrument/analyser IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Roche Diagnostics Australia Pty Limited, manufactured by FFEI Ltd in United Kingdom. The device registration started on May 08, 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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TGA ARTG Official Data
Class I
Class I
Instrument/analyser IVDs
Australia TGA ARTG Registered Device
Good Name: Roche Diagnostics Australia Pty Limited - Instrument/analyser IVDs
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Intended Purpose

Instruments that are intended to be used as an IVD for the purposes of processing, examining and/or providing information about a clinical specimen

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
May 08, 2018
Effective Date
May 08, 2018
Sponsor
Manufacturer
Country
United Kingdom
Address
The Cube Maylands Avenue, Hemel Hempstead, HP2 7DF