Australia TGA ARTG record

Information system software, application program, home healthcare

Australia TGA ARTG Registered Device · Roche Diabetes Care Australia Pty Ltd · Roche Diabetes Care GmbH · Class IIb · Started November 28, 2019

Good Name: Roche Diabetes Care Australia Pty Ltd - Information system software, application program, home healthcare

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

Sponsor

Name: Roche Diabetes Care Australia Pty Ltd

Manufacturer

Name: Roche Diabetes Care GmbH
Country: Germany
Address: Sandhofer strasse 116, Mannheim, 68305

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.

About this record

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.