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Insight Lifetech VivoHeart Intravascular Ultrasound Imaging System - HSA Registration DE0510459

Access comprehensive regulatory information for Insight Lifetech VivoHeart Intravascular Ultrasound Imaging System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510459 and owned by Insight Lifetech Co., Ltd.. The device was registered on March 13, 2025.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0510459
Insight Lifetech VivoHeart Intravascular Ultrasound Imaging System
HSA Registration Number: DE0510459
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Product Description

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.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0510459
Registration Date
March 13, 2025
Retention Due Date
March 12, 2026
Product Owner
Short Name
Insight Lifetech Co., Ltd.
Address
Zone E, 3rd Floor, Building 3, Tinwe Business Park, No.6 Liufang Road, Baoan District, Shenzhen, Guangdong 518000, CHINA
Registrant
Address
36 JALAN TUKANG, SINGAPORE 619266
Importer
Address
36 JALAN TUKANG, SINGAPORE 619266
Model Information
Model Name(s)
VivoHeart Intravascular Ultrasound Imaging System
Model Identifier(s)
VH-60