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Infusion pump, insulin, ambulatory

Access comprehensive regulatory information for Infusion pump, insulin, ambulatory in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Ypsomed Australia Pty Ltd, manufactured by Ypsomed AG in Switzerland. The device registration started on January 04, 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 pump, insulin, ambulatory
Australia TGA ARTG Registered Device
Good Name: Ypsomed Australia Pty Ltd - Infusion pump, insulin, ambulatory
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Intended Purpose

A pack consisting of five devices required for continuous subcutaneous insulin delivery to individuals with diabetes mellitus (i.e. pump, software, reservoir, infusion set, inserter). Each component is separately included on the ARTG for individual supply as required.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
January 04, 2018
Effective Date
January 04, 2018
Manufacturer
Country
Switzerland
Address
Brunnmattstrasse 6, BURGDORF, Burgdorf, CH-3401