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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 Cyclomedica Australia Pty Ltd, manufactured by Mirion Technologies (Capintec) Inc in United States of America. The device registration started on December 24, 2021.

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

The device is used for quantifying the amount of radiation in a radio-pharmaceutical dose or other test samples inserted into a shielded chamber or well for measurement. It is used to measure the radioactivity in diagnostic or therapeutic radio-pharmaceuticals prior to and after patient administration.

Device Classification
Risk Class
Class Im
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
December 24, 2021
Effective Date
December 24, 2021
Manufacturer
Country
United States of America
Address
7 Vreeland Road, Florham Park, NJ, 07932