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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 Ablynx NV in Belgium. The device registration started on April 29, 2020.

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

Cablivi (AUST R 318058) is indicated for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), in conjunction with plasma exchange and immunosuppression. Each pack contains a caplacizumab powder vial and prefilled diluent syringe supplied together with a vial adapter, needle and swabs suitable for administration. Packs of 1x or 7x all components.

Device Classification
Risk Class
Class IIa
Product Type
Procedure Pack
ARTG Category
General
Registration Information
Start Date
April 29, 2020
Effective Date
April 29, 2020
Manufacturer
Country
Belgium
Address
Technologiepark 21, Zwijnaarde, 9052