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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 October 12, 2018.

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

Adacel (AUST R 297685) is a pertussis vaccine - acellular combined with diphtheria and tetanus toxoids (adsorbed) 0.5mL injection in pre-filled needle-free syringe. Separate needle (either 1 or 2) will be provided in each pack of Adacel syringe for administration.

Device Classification
Risk Class
Class IIa
Product Type
Procedure Pack
ARTG Category
General
Registration Information
Start Date
October 12, 2018
Effective Date
October 12, 2018
Manufacturer
Country
France
Address
14 Espace Henry Vallee, Lyon, 69007