ARTG 460767VivoHeart Intravascular Ultrasound Imaging System - Ultrasound system, imaging, cardiovascular
ARTG ID: 460767 · Bio-Excel Australia Pty Ltd · Insight Lifetech Co Ltd · Class IIb · Started August 27, 2024
Good Name: Bio-Excel Australia Pty Ltd - VivoHeart Intravascular Ultrasound Imaging System - Ultrasound system, imaging, cardiovascular
- Risk Class
- Class IIb
- Product Type
- Medical device system
- ARTG Category
- General
- ARTG ID
- 460767
- Start Date
- August 27, 2024
- Effective Date
- August 27, 2024
- Country
- China
- Address
- Zone E 3rd Floor Building 3 Tinwe Business Park No6 Liufang Road Baoan District, Shenzhen, Guangdong, 518000
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.
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.
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