Australia TGA ARTG record

Basic insulin pen, replaceable-cartridge

Australia TGA ARTG Registered Device · Gedeon Richter Australia Pty Ltd · Gedeon Richter PLC · Class IIa · Started March 18, 2021

Good Name: Gedeon Richter Australia Pty Ltd - Basic insulin pen, replaceable-cartridge

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

Sponsor

Name: Gedeon Richter Australia Pty Ltd

Manufacturer

Name: Gedeon Richter PLC
Country: Hungary
Address: 19-21 Gyomroi ut, Budapest, 1103

Intended purpose

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

About this record

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.