Australia TGA ARTG record

Medicine administration kit, percutaneous, medicated, single-use

Australia TGA ARTG Registered Device · Sanofi-Aventis Australia Pty Ltd · Sanofi Pasteur · Class IIa · Started November 07, 2016

Good Name: Sanofi-Aventis 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: November 07, 2016
Effective Date: November 07, 2016

Sponsor

Name: Sanofi-Aventis Australia Pty Ltd

Manufacturer

Name: Sanofi Pasteur
Country: France
Address: 1541 Avenue Marcel Merieux, 69280 Marcy L'Etoile

Intended purpose

Hexaxim (Diphtheria, tetanus, pertussis (acellular component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed) [DTPa-hepB-IPV-Hib]) is indicated for vaccination of infants from 6 weeks of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type b. Hexaxim consists of needleless pre-filled syringe containing the vaccine and 2 separate needles (25mm x 23G and 15mm x 25G) per syringe for administration.

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 Sanofi-Aventis Australia Pty Ltd, manufactured by Sanofi Pasteur in France. The device registration started on November 07, 2016.

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.