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CT contrast medium injection system, line-powered, mobile - ARTG 407533

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 registered under ARTG number 407533 and sponsored by Imaxeon Pty Ltd, manufactured by Bayer Medical Care Inc in United States of America. The device registration started on April 12, 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 407533
Class IIb
CT contrast medium injection system, line-powered, mobile
ARTG ID: 407533
Good Name: Imaxeon Pty Ltd - CT contrast medium injection system, line-powered, mobile
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Intended Purpose

The device is intended to provide powered injection of imaging agents (saline, contrast media) in radiological diagnostic procedures.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
407533
Start Date
April 12, 2023
Effective Date
April 12, 2023
Sponsor
Manufacturer
Country
United States of America
Address
1 Bayer Drive, Indianola, PA, 15051-0780