Singapore HSA registration DE0510459
Insight Lifetech VivoHeart Intravascular Ultrasound Imaging System
Singapore·CLASS B·Insight Lifetech Co., Ltd.·Registered March 13, 2025Device 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 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.
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
About this record
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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