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Infusion administration set, insulin pump

Access comprehensive regulatory information for Infusion administration set, insulin pump 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 August 28, 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
Infusion administration set, insulin pump
Australia TGA ARTG Registered Device
Good Name: Roche Diabetes Care Australia Pty Ltd - Infusion administration set, insulin pump
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Intended Purpose

The Accu-Chek Solo Reservoir is a sterile part of the micropump used as a container for holding the insulin that the micropump delivers to the body.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
August 28, 2018
Effective Date
August 28, 2018
Manufacturer
Country
Germany
Address
Sandhofer strasse 116, Mannheim, 68305