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General laboratoryware IVDs - ARTG 445548

Access comprehensive regulatory information for General laboratoryware IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 445548 and sponsored by Southern Cross Diagnostics Pty Ltd, manufactured by Orgentec Diagnostika GmbH in Germany. The device registration started on April 08, 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 I
ARTG 445548
Class I
General laboratoryware IVDs
ARTG ID: 445548
Good Name: Southern Cross Diagnostics Pty Ltd - General laboratoryware IVDs
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Intended Purpose

General reagents and consumables intended by the manufacturer to be used by pathology laboratories in manual, semi-automated or automated clinical chemistry IVD procedures.

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
445548
Start Date
April 08, 2024
Effective Date
April 08, 2024
Manufacturer
Country
Germany
Address
Carl-Zeiss-Strasse 49-51, Mainz, 55129