Australia TGA ARTG recordMedicine administration kit, percutaneous, medicated, single-use
Australia TGA ARTG Registered Device · Sanofi-Aventis Australia Pty Ltd · Sanofi Pasteur · Class IIa · Started January 18, 2018
Good Name: Sanofi-Aventis Australia Pty Ltd - Medicine administration kit, percutaneous, medicated, single-use
- Risk Class
- Class IIa
- Product Type
- Procedure Pack
- ARTG Category
- General
- Start Date
- January 18, 2018
- Effective Date
- January 18, 2018
- Name
- Sanofi Pasteur
- Country
- France
- Address
- 1541 Avenue Marcel Merieux, 69280 Marcy L'Etoile
Act-HIB (AUST R 130161) contains Haemophilus type b conjugate vaccine powder in vial, sodium chloride solution (diluent for reconstitution) in pre-filled syringe without attached needle and separate needles. There are 2 pack sizes; the single pack contains 1 vaccine vial, 1 diluent syringe and 2 needles and the 10 pack contains 10 vaccine vials, 10 diluent syringes and 20 needles. The needles are required for reconstitution and administration of reconstituted solution.
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 18, 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.