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Radioisotope calibration system

Access comprehensive regulatory information for Radioisotope calibration system 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 March 02, 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.

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Class Im
Class Im
Radioisotope calibration system
Australia TGA ARTG Registered Device
Good Name: Imaxeon Pty Ltd - Radioisotope calibration system
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Intended Purpose

The intended use for the device is for automatic dispensing of radiopharmaceuticals in syringes or vials for the purpose of minimizing the amount of radiopharmaceuticals absorbed by operators and guaranteeing the sterility of the doses produced.

Device Classification
Risk Class
Class Im
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
March 02, 2016
Effective Date
March 02, 2016
Sponsor
Manufacturer
Country
Italy
Address
Via Malpighi 120, Faenza, Ravenna, 48018