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Medicine administration kit, percutaneous, medicated, single-use

Australia TGA ARTG Registered Device · Gedeon Richter Australia Pty Ltd · Gedeon Richter PLC · Class IIa · Started March 12, 2019

Good Name: Gedeon Richter Australia Pty Ltd - Medicine administration kit, percutaneous, medicated, single-use

Device classification
Risk Class
Class IIa
Product Type
Procedure Pack
ARTG Category
General
Registration information
Start Date
March 12, 2019
Effective Date
March 12, 2019
Sponsor
Manufacturer
Country
Hungary
Address
19-21 Gyomroi ut, Budapest, 1103
Intended purpose

A procedure pack used to administer medication by injection. It contains a Afolia pre-filled pen of various strengths and corresponding number of administration needles. This is a single use device.

About this record

Access comprehensive regulatory information for Medicine administration kit, percutaneous, medicated, single-use 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 12, 2019.

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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