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Diabetes patient management software - ARTG 296368

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 IIb is registered under ARTG number 296368 and sponsored by Ypsomed Australia Pty Ltd, manufactured by SINOVO health solutions GmbH in Germany. The device registration started on November 16, 2017.

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 IIb
ARTG 296368
Class IIb
Diabetes patient management software
ARTG ID: 296368
Good Name: Ypsomed Australia Pty Ltd - Diabetes patient management software
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Intended Purpose

The mylife App is intended to be used by persons with diabetes and/or their caregivers. The mylife App is an application for smartphones that allows you to log therapy data and calculate bolus suggestions for delivery. In addition, data can be read from the mylife YpsoPump as well as from the connectable devices such as the mylife Unio Neva and mylife Aveo blood glucose meters and the Dexcom G6 CGM system via their Bluetooth interfaces. Logged therapy data like carbohydrate estimates, blood glucose measurements and real-time Dexcom G6 CGM data may be used for therapy decisions supported by the mylife App. The mylifeโ„ข App is able to initiate boluses on the mylifeโ„ข Ypsopumpยฎ (selected pump versions).

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
296368
Start Date
November 16, 2017
Effective Date
November 16, 2017
Manufacturer
Country
Germany
Address
Willy-Brandt-Strasse 4, Bad Vilbel, 61118