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Infusion administration set, insulin pump - ARTG 297381

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 IIa is registered under ARTG number 297381 and sponsored by Ypsomed Australia Pty Ltd, manufactured by Ypsomed AG in Switzerland. The device registration started on December 11, 2017.

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 IIa
ARTG 297381
Class IIa
Infusion administration set, insulin pump
ARTG ID: 297381
Good Name: Ypsomed Australia Pty Ltd - Infusion administration set, insulin pump
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Intended Purpose

An empty reservoir that is intended to be filled with insulin by the patient just prior to use as a reservoir to facilitate continuous subcutaneous infusion of insulin from an insulin pump. This is a sterile, single-use item.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
297381
Start Date
December 11, 2017
Effective Date
December 11, 2017
Manufacturer
Country
Switzerland
Address
Brunnmattstrasse 6, 3401, Burgdorf, Switzerland