Australia TGA ARTG record

Basic intravenous administration set

Australia TGA ARTG Registered Device · Regional Health Care Group Pty Ltd · Bracco Injeneering S A · Class IIa · Started November 23, 2012

Good Name: Regional Health Care Group Pty Ltd - Basic intravenous administration set

Device classification

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

Registration information

Start Date: November 23, 2012
Effective Date: November 23, 2012

Sponsor

Name: Regional Health Care Group Pty Ltd

Manufacturer

Name: Bracco Injeneering S A
Country: Switzerland
Address: Avenue de Sevelin 46, Lausanne, CH-1004

Intended purpose

This device is a contrast administration set line, delivering contrast medium to the patient. It is a disposable device to be used as part of the CT Expres system. The CT Expres Contrast Media Delivery System is indicated for controlled automatic venous-side administration of contrast media to human subjects while undergoing examination by means of a computed tomography (CT) scanner, including CT angiography (CTA). This device is not intended for injection of contrast media for coronary arteriography, or for any other use for which the device is not indicated.

About this record

Access comprehensive regulatory information for Basic intravenous administration set in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Regional Health Care Group Pty Ltd, manufactured by Bracco Injeneering S A in Switzerland. The device registration started on November 23, 2012.

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.