Pure Global

Medicine administration kit, percutaneous, medicated, single-use

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 Sanofi-Aventis Australia Pty Ltd, manufactured by Sanofi Pasteur in France. The device registration started on January 17, 2013.

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
Medicine administration kit, percutaneous, medicated, single-use
Australia TGA ARTG Registered Device
Good Name: Sanofi-Aventis Australia Pty Ltd - Medicine administration kit, percutaneous, medicated, single-use
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Intended Purpose

AVAXIM is a vaccine indicated for active immunisation against hepatitis A infection in adults and children 2 years and over. Each pack contains one dose of vaccine supsension in a pre-filled syringe without attached needle and two separate needles (16mm and 25mm) for administration.

Device Classification
Risk Class
Class IIa
Product Type
Procedure Pack
ARTG Category
General
Registration Information
Start Date
January 17, 2013
Effective Date
January 17, 2013
Manufacturer
Country
France
Address
14 Espace Henry Vallee, Lyon, 69007