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MRI contrast medium injection system, battery-powered - ARTG 410692

Access comprehensive regulatory information for MRI contrast medium injection system, battery-powered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 410692 and sponsored by Imaxeon Pty Ltd, manufactured by Bayer Medical Care Inc in United States of America. The device registration started on June 16, 2023.

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 IIb
ARTG 410692
Class IIb
MRI contrast medium injection system, battery-powered
ARTG ID: 410692
Good Name: Imaxeon Pty Ltd - MRI contrast medium injection system, battery-powered
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Intended Purpose

This system is intended for the purposes of injecting intravenous MR contrast media and common flushing solutions into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI) procedures

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
410692
Start Date
June 16, 2023
Effective Date
June 16, 2023
Sponsor
Manufacturer
Country
United States of America
Address
1 Bayer Drive, Indianola, PA, 15051-0780