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Infusion pump, general-purpose

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.

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TGA ARTG Official Data
Class Im
Class Im
Infusion pump, general-purpose
Australia TGA ARTG Registered Device
Good Name: Imaxeon Pty Ltd - Infusion pump, general-purpose
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Intended Purpose

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.

Device Classification
Risk Class
Class Im
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
November 01, 2013
Effective Date
November 01, 2013
Sponsor
Manufacturer
Country
Italy
Address
Via Malpighi 120, Faenza, Ravenna, 48018