Singapore HSA registration DE0007633
Edwards Lifesciences Vigileo Patient Monitor
Singapore·CLASS C·Edwards Lifesciences LLC·Registered September 22, 2011Device 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 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.
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
- Name
- EDWARDS LIFESCIENCES (SINGAPORE) PTE. LTD. MLS LOGISTIC SERVICES PTE. LTD. ZUELLIG PHARMA PTE LTD
- 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 , pressure line 152cm, 60" tubing FloTrac Sensor with VAMP kit, pressure line 152cm (60") FloTrac Sensor , 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
About this record
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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