Singapore HSA registration DE0011398
Edwards EV1000 Clinical Platform
Singapore·CLASS C·Edwards Lifesciences LLC·Registered October 22, 2012Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Cardiovascular
- HSA Product Code
- Refer to CRPNS
- HS Code
- 90189030
Registration information
- Registration Number
- DE0011398
- Registration Date
- October 22, 2012
- Change Notification Approval Date
- August 02, 2021
- Retention Due Date
- October 21, 2025
Product description
The EV1000 is indicated primarily for critical care patients in which the balance between oxygen delivery and consumption, cardiac function, fluid status and vascular resistance needs continuous or intermittent assessment. Analysis of the thermodilution curve in terms of mean transit time and shape is used to determine intravascular and extravascular fluid volumes. The EV1000 platform may be used in all settings in which critical care is provided.
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)
- EV1000 Platform EV1000 Databox EV1000 Monitor EV1000 Databox Transducer Holder Ethernet Cable Ethernet Cable-15 Fleet FloTrac Cable FloTrac Cable-15 Fleet EV1000 Monitor Bracket Power Adaptor Mounting Bracket EV1000 Power Adaptor, 110V EV1000 Power Adaptor, 110V-15Fleet EV1000 Power Adaptor, 110V EV1000 Power Adaptor, 110V-15Fleet EV1000 Power Adaptor, 220V EV1000 Power Adaptor, 220V-15Fleet EV Table Stand EV1000 VolumeView Thermodilution Cable Optical Module Optical Module (CE)
- Model Identifier(s)
- EV1000A EV1000DB EV1000M EVDTH4 EVEC1 EVECL EVFTC1 EVFTCL EVMB1 EVPB1 EVPSA110 EVPSA110L EVPSB110 EVPSB110L EVPSB220 EVPSB220L EVS1 EVVVTC1 OM2 OM2E
About this record
Access comprehensive regulatory information for Edwards EV1000 Clinical Platform in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0011398 and owned by Edwards Lifesciences LLC. The device was registered on October 22, 2012.
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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