VivoHeart Intravascular Ultrasound Imaging System - Ultrasound system, imaging, cardiovascular - ARTG 460767
Access comprehensive regulatory information for VivoHeart Intravascular Ultrasound Imaging System - Ultrasound system, imaging, cardiovascular in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 460767 and sponsored by Bio-Excel Australia Pty Ltd, manufactured by Insight Lifetech Co Ltd in China. The device registration started on August 27, 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.
The VivoHeart Intravascular Ultrasound Imaging System is intended to be used in medical institutions in conjunction with the TrueVision Intravascular Ultrasound Imaging Catheter for ultrasonic examination of intravascular lesions in coronary arteries. It is indicated for patients with intra-vascular stenoses requiring transluminal coronary interventional procedures.