Australia TGA ARTG record

CT contrast medium injection system, line-powered, mobile

Australia TGA ARTG Registered Device · Imaxeon Pty Ltd · Imaxeon Pty Ltd · Class IIb · Started December 11, 2017

Good Name: Imaxeon Pty Ltd - CT contrast medium injection system, line-powered, mobile

Device classification

Risk Class: Class IIb
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: December 11, 2017
Effective Date: December 11, 2017

Sponsor

Name: Imaxeon Pty Ltd

Manufacturer

Name: Imaxeon Pty Ltd
Country: Australia
Address: Unit 1 / 38-46 South Street, RYDALMERE, NSW, 2116

Intended purpose

The injector is intended to be used specifically for the purposes of venous injections of contrast agents and common flushing solutions into adult and paediatric patients during x-ray imaging procedures.

About this record

Access comprehensive regulatory information for CT contrast medium injection system, line-powered, mobile 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 Imaxeon Pty Ltd in Australia. The device registration started on December 11, 2017.

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.