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Self-care monitoring web-based application software - ARTG 392894

Access comprehensive regulatory information for Self-care monitoring web-based application software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 392894 and sponsored by Roche Diabetes Care Australia Pty Ltd, manufactured by mySugr GmbH in Austria. The device registration started on July 27, 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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Class IIa
ARTG 392894
Class IIa
Self-care monitoring web-based application software
ARTG ID: 392894
Good Name: Roche Diabetes Care Australia Pty Ltd - Self-care monitoring web-based application software
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Intended Purpose

An app that serves as a logbook that is used to support the treatment of diabetes through daily diabetes-related data management and aims to support the optimization of therapy. You can manually create log entries that include information about your insulin therapy, current & target blood sugar levels, carbohydrate intake & details of your activities. Additionally, you can synchronize other therapy devices such as blood sugar meters to mitigate errors caused by manually entering values and to better your confidence in usage.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
392894
Start Date
July 27, 2022
Effective Date
July 27, 2022
Manufacturer
Country
Austria
Address
Trattnerhof 1/5 OG, Wien, Vienna, 1010