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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 Diagnostic Technology Pty Ltd, manufactured by Hamilton Bonaduz AG in Switzerland. The device registration started on February 23, 2022.

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: Diagnostic Technology Pty Ltd - Software IVDs
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Intended Purpose

Software that is intended to be incorporated into an IVD instrument to supplement operational functions including the processing of clinical specimens

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
February 23, 2022
Effective Date
February 23, 2022
Manufacturer
Country
Switzerland
Address
Via Crusch 8, Bonaduz, 7402