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TrueVision Intravascular Ultrasound Imaging Catheter - Transducer assembly, ultrasound, diagnostic, intracorporeal, intravascular, single-use - ARTG 465805

Access comprehensive regulatory information for TrueVision Intravascular Ultrasound Imaging Catheter - Transducer assembly, ultrasound, diagnostic, intracorporeal, intravascular, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 465805 and sponsored by Bio-Excel Australia Pty Ltd, manufactured by Insight Lifetech Co Ltd in China. The device registration started on October 24, 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.

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TGA ARTG Official Data
Class III
ARTG 465805
Class III
TrueVision Intravascular Ultrasound Imaging Catheter - Transducer assembly, ultrasound, diagnostic, intracorporeal, intravascular, single-use
ARTG ID: 465805
Good Name: Bio-Excel Australia Pty Ltd - TrueVision Intravascular Ultrasound Imaging Catheter - Transducer assembly, ultrasound, diagnostic, intracorporeal, intravascular, single-use
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Intended Purpose

The TrueVision Intravascular Ultrasound Imaging Catheter is intended to be used for ultrasonic examination of intravascular lesions in coronary arteries to diagnose intra-vascular stenoses. The catheter is used with the VivoHeart Intravascular Ultrasound Imaging System. It is indicated for patients with intra-vascular stenoses requiring transluminal coronary interventional procedures

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
465805
Start Date
October 24, 2024
Effective Date
October 24, 2024
Manufacturer
Country
China
Address
Zone E 3rd Floor Building 3 Tinwe Business Park No6 Liufang Road Baoan District, Shenzhen, Guangdong, 518000