Australia TGA ARTG recordInfusion pump, general-purpose
Australia TGA ARTG Registered Device · Imaxeon Pty Ltd · Tema Sinergie Srl · Class Im · Started November 01, 2013
Good Name: Imaxeon Pty Ltd - Infusion pump, general-purpose
- Risk Class
- Class Im
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- November 01, 2013
- Effective Date
- November 01, 2013
- Name
- Imaxeon Pty Ltd
- Country
- Italy
- Address
- Via Malpighi 120, Faenza, Ravenna, 48018
The device is intended for the automatic dispensing of radiopharmaceuticals in syringes or vials for the purpose of minimising the amount of radiopharmaceuticals absorbed by operators and guaranteeing the sterility of the doses produced. The device consists of a peristaltic pump. An administration set connects the pump to a mother radiopharmaceutical vial and then to a syringe. The syringe is filled, and dismounted from the system to be used on a separate infusion pump.
Access comprehensive regulatory information for Infusion pump, general-purpose in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Im is sponsored by Imaxeon Pty Ltd, manufactured by Tema Sinergie Srl in Italy. The device registration started on November 01, 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.