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Contrast medium injection system hand controller

Australia TGA ARTG Registered Device · Imaxeon Pty Ltd · Bayer Medical Care Inc · Class I · Started May 24, 2023

Good Name: Imaxeon Pty Ltd - Contrast medium injection system hand controller

Device classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration information
Start Date
May 24, 2023
Effective Date
May 24, 2023
Sponsor
Manufacturer
Country
United States of America
Address
1 Bayer Drive, Indianola, PA, 15051-0780
Intended purpose

An optional hand-held, electronic device designed to be used as part of a injection system to instantaneously stop/start the administration of a contrast medium or saline solution to a patient undergoing a diagnostic imaging procedure. This is a reusable device typically connected via an electrical cable

About this record

Access comprehensive regulatory information for Contrast medium injection system hand controller in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Imaxeon Pty Ltd, manufactured by Bayer Medical Care Inc in United States of America. The device registration started on May 24, 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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