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Information system software, application program, home healthcare

Access comprehensive regulatory information for Information system software, application program, home healthcare in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Roche Diabetes Care Australia Pty Ltd, manufactured by Roche Diabetes Care GmbH in Germany. The device registration started on November 28, 2019.

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 IIb
Class IIb
Information system software, application program, home healthcare
Australia TGA ARTG Registered Device
Good Name: Roche Diabetes Care Australia Pty Ltd - Information system software, application program, home healthcare
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Pricing
Intended Purpose

An app that is indicated as an aid in the treatment of diabetes. The software provides for electronic download of blood glucose meters, manual data entry, storage, display, transfer, and self-managing of blood glucose and other related health indicators which can be shown in report and graphical format.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
November 28, 2019
Effective Date
November 28, 2019
Manufacturer
Country
Germany
Address
Sandhofer strasse 116, Mannheim, 68305