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Needle, subcutaneous injection/infusion port

Access comprehensive regulatory information for Needle, subcutaneous injection/infusion port in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Medtronic Australasia Pty Ltd, manufactured by Unomedical A/S in Denmark. The device registration started on August 19, 2014.

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
Needle, subcutaneous injection/infusion port
Australia TGA ARTG Registered Device
Good Name: Medtronic Australasia Pty Ltd - Needle, subcutaneous injection/infusion port
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Intended Purpose

The i-port Advanceโ„ข injection port is indicated for patients who administer, or to whom is administered, multiple daily subcutaneous injections of physician prescribed medications, including insulin.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
August 19, 2014
Effective Date
August 19, 2014
Manufacturer
Country
Denmark
Address
Aaholmvej 1-3, Osted, Lejre, 4320