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Hepatitis E virus IVDs - ARTG 441110

Access comprehensive regulatory information for Hepatitis E virus IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 441110 and sponsored by Roche Diagnostics Australia Pty Limited, manufactured by Roche Diagnostics GmbH in Germany. The device registration started on February 15, 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 441110
Class IIb
Hepatitis E virus IVDs
ARTG ID: 441110
Good Name: Roche Diagnostics Australia Pty Limited - Hepatitis E virus IVDs
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Intended Purpose

For the in vitro quantitative and/or qualitative determination of Hepatitis E antibodies in human clinical samples to provide information about the status of infection

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
441110
Start Date
February 15, 2024
Effective Date
February 15, 2024
Manufacturer
Country
Germany
Address
Sandhofer Strasse 116, Mannheim, D-68305