Clinical data collection/management information application software
Access comprehensive regulatory information for Clinical data collection/management information application software 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 mySugr GmbH in Austria. The device registration started on July 11, 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.
The mySugr Bolus Calculator is intended for the management of insulin dependent diabetes by calculating a bolus insulin dose or carbohydrate intake based on your entered data. Before its use, you perform a set-up by providing your specific target blood glucose, insulin to carbohydrate ratio, insulin sensitivity parameters and insulin action time. For the calculation, in addition to the set-up parameters that you provide, the algorithm uses current blood glucose values, ingested carbohydrates and the current insulin on board which is calculated based on the insulin action curves of the respective insulin type.