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Edwards Lifesciences Vigileo Patient Monitor - HSA Registration DE0007633

Access comprehensive regulatory information for Edwards Lifesciences Vigileo Patient Monitor in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0007633 and owned by Edwards Lifesciences LLC. The device was registered on September 22, 2011.

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
DE0007633
Edwards Lifesciences Vigileo Patient Monitor
HSA Registration Number: DE0007633
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Product Description

Intended to measure APCO and oximetry. The system also calculates derived hemodynamic and oxygenation parameters. Indicated for use for continuously measuring hemodynamic parameters such as cardiac output and oximetry to assess oxygen delivery and consumption.The FloTrac sensor is intended to measure intravascular pressures and transmit those pressure readings to both a standard blood pressure monitor and to the Vigileo monitor.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Cardiovascular
HSA Product Code
Refer to CRPNS
HS Code
90189030
Registration Information
Registration Number
DE0007633
Registration Date
September 22, 2011
Change Notification Approval Date
August 22, 2020
Retention Due Date
September 21, 2025
Product Owner
Short Name
Edwards Lifesciences
Address
One Edwards Way, Irvine, CA 92614, UNITED STATES
Registrant
Address
238B THOMSON ROAD, NOVENA SQUARE, #18-01/08, SINGAPORE 307685
Importer
Address
35 CHANGI NORTH CRESCENT, SINGAPORE 499641 5 TAI SENG DRIVE, SCA CREATIVE CENTRE, #02-01, SINGAPORE 535217 15 CHANGI NORTH WAY, #01-00, SINGAPORE 498770
Model Information
Model Name(s)
Cable for Detex Catheter interface cable CCO In-line Temperature Probe Viligeo Connecting Cable FloTrac Sensor ย , pressure line 152cm, 60" tubing FloTrac Sensor ย with VAMP kit, pressure line 152cm (60") FloTrac Sensor ย , pressure line 213m, 84" tubing Vigileo Monitor Vigileo & Vigilance accessories: Optical Module Cable
Model Identifier(s)
64EKD2 70CC2 93522 APC09 MHD6 MHD6AZ MHD8 MHM1E OM2/ OM2E