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Diabetes patient management software

Access comprehensive regulatory information for Diabetes patient management software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Ypsomed Australia Pty Ltd, manufactured by SINOVO health solutions GmbH in Germany. The device registration started on November 16, 2023.

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 IIa
Class IIa
Diabetes patient management software
Australia TGA ARTG Registered Device
Good Name: Ypsomed Australia Pty Ltd - Diabetes patient management software
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Intended Purpose

The mylife Software is a readout software for event history and device settings from the mylife Ypsopump insulin pump and from a defined product range of glucose meters (BGM/CGM) which enables diabetes therapy management. The software further offers manual data entry, logbook, statistical evaluation, graphical presentation, report functions and multi-patient management. The mylife Software is intended to exist in two versions: As a standalone PC version and a browser-based online version. Both versions have the same functionality and close-to identical user interfaces (depending on PC settings and browser capabilities). Patients and healthcare professionals may use both versions.The online version can be used to synchronize and store patient data persistently. The data synchronization takes place between the system clients, e.g. between the mylife Software PC version and the browser version and/or between the mylife App and the online version.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
November 16, 2023
Effective Date
November 16, 2023
Manufacturer
Country
Germany
Address
Willy-Brandt-Strasse 4, Bad Vilbel, 61118