Australia TGA ARTG record

Clinical data collection/management information application software

Australia TGA ARTG Registered Device · Roche Diabetes Care Australia Pty Ltd · Roche Diabetes Care GmbH · Class IIa · Started November 07, 2023

Good Name: Roche Diabetes Care Australia Pty Ltd - Clinical data collection/management information application software

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: November 07, 2023
Effective Date: November 07, 2023

Sponsor

Name: Roche Diabetes Care Australia Pty Ltd

Manufacturer

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

Intended purpose

A software application for healthcare professionals (HCPs) and people with diabetes (PwDs). It is intended as an aid in the treatment of diabetes. This information management tool will help HCPs, PwDs and caregivers to monitor, organize and visualize at a glance the information related to their patients and their diabetes-related data.

About this record

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 IIa is sponsored by Roche Diabetes Care Australia Pty Ltd, manufactured by Roche Diabetes Care GmbH in Germany. The device registration started on November 07, 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.