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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 IIb is sponsored by Imaxeon Pty Ltd, manufactured by Tema Sinergie Srl in Italy. The device registration started on October 21, 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 IIb
Class IIb
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 administering automatic intravenous injections of radiopharmaceuticals for nuclear medicine applications. The device is also intended to provide effective radiation shielding to the medical personnel from radiation exposure during the administration procedure.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
October 21, 2013
Effective Date
October 21, 2013
Sponsor
Manufacturer
Country
Italy
Address
Via Malpighi 120, Faenza, Ravenna, 48018