Pure Global

Contrast medium injection system hand controller kit

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIb
Class IIb
Contrast medium injection system hand controller kit
Australia TGA ARTG Registered Device
Good Name: Imaxeon Pty Ltd - Contrast medium injection system hand controller kit
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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.

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
Manufacturer
Country
United States of America
Address
1 Bayer Drive, Indianola, PA, 15051-0780