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Ambulatory insulin infusion pump/blood glucose analyser system

Access comprehensive regulatory information for Ambulatory insulin infusion pump/blood glucose analyser system 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 12, 2018.

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 IIb
Class IIb
Ambulatory insulin infusion pump/blood glucose analyser system
Australia TGA ARTG Registered Device
Good Name: Roche Diabetes Care Australia Pty Ltd - Ambulatory insulin infusion pump/blood glucose analyser system
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Intended Purpose

Intended for the subcutaneous continuous delivery of insulin via customizable hourly rates, for the management of diabetes mellitus in persons requiring insulin as prescribed by a physician.

Device Classification
Risk Class
Class IIb
Product Type
Procedure Pack
ARTG Category
General
Registration Information
Start Date
November 12, 2018
Effective Date
November 12, 2018
Manufacturer
Country
Germany
Address
Sandhofer strasse 116, Mannheim, 68305