Australia TGA ARTG record

Contrast medium injection system hand controller kit

Australia TGA ARTG Registered Device · Imaxeon Pty Ltd · Bayer Medical Care Inc · Class IIb · Started July 15, 2024

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

Device classification

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

Registration information

Start Date: July 15, 2024
Effective Date: July 15, 2024

Sponsor

Name: Imaxeon Pty Ltd

Manufacturer

Name: Bayer Medical Care Inc
Country: United States of America
Address: 1 Bayer Drive, Indianola, PA, 15051-0780

Intended purpose

The device is an accessory and intended to be used with an injection system for the administration of a contrast medium or saline solution to a patient undergoing a diagnostic imaging procedure.

About this record

Access comprehensive regulatory information for Contrast medium injection system hand controller kit 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 Bayer Medical Care Inc in United States of America. The device registration started on July 15, 2024.

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.