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Basic insulin pen, replaceable-cartridge

Access comprehensive regulatory information for Basic insulin pen, replaceable-cartridge in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Gedeon Richter Australia Pty Ltd, manufactured by Gedeon Richter PLC in Hungary. The device registration started on March 18, 2021.

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
Class IIa
Basic insulin pen, replaceable-cartridge
Australia TGA ARTG Registered Device
Good Name: Gedeon Richter Australia Pty Ltd - Basic insulin pen, replaceable-cartridge
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Intended Purpose

An administration kit that may contain a pen for injection or similar medicine injector, needles, and cartridges or ampoules of medication.

Device Classification
Risk Class
Class IIa
Product Type
Procedure Pack
ARTG Category
General
Registration Information
Start Date
March 18, 2021
Effective Date
March 18, 2021
Manufacturer
Country
Hungary
Address
19-21 Gyomroi ut, Budapest, 1103