Singapore HSA registration DE0509938
Insight Lifetech VivoCardio Cardiovascular Pressure Measurement (CPM) System
Singapore·CLASS C·Insight Lifetech Co., Ltd.·Registered October 22, 2024Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0509938
- Registration Date
- October 22, 2024
- Change Notification Approval Date
- April 16, 2025
- Retention Due Date
- October 21, 2025
Product description
VivoCardio CPM System is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display systolic pressure, diastolic pressure, mean pressure, FFR and cRR based on the output from one or more electrodes, transducers or measuring devices. VivoCardio CPM System is indicated to provide hemodynamic information for the diagnosis and treatment of patients that undergo measurement of blood pressure with Pressure Microcatheter. The VivoCardio CPM System is intended for adult patients (≥18 years) with coronary heart disease requiring diagnosis of functional stenosis severity.
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)
- VivoCardio Cardiovascular Pressure Measurement (CPM) System
- Model Identifier(s)
- U152301
About this record
Access comprehensive regulatory information for Insight Lifetech VivoCardio Cardiovascular Pressure Measurement (CPM) System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509938 and owned by Insight Lifetech Co., Ltd.. The device was registered on October 22, 2024.
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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