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Insight Lifetech VivoCardio Cardiovascular Pressure Measurement (CPM) System - HSA Registration DE0509938

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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CLASS C
DE0509938
Insight Lifetech VivoCardio Cardiovascular Pressure Measurement (CPM) System
HSA Registration Number: DE0509938
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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 (โ‰ฅ18 years) with coronary heart disease requiring diagnosis of functional stenosis severity.

Device 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 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