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Singapore HSA registration DE0019311

EDWARDS LIFESCIENCES EV1000 Clinical Platform NI

Singapore flagSingapore·CLASS C·Edwards Lifesciences LLC·Registered June 09, 2017
Device classification
Device Class
CLASS C
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0019311
Registration Date
June 09, 2017
Change Notification Approval Date
October 22, 2021
Retention Due Date
June 08, 2025
Product description
The EV1000 Clinical Platform NI is indicated for use in patients over 18 years of age in which the balance between cardiac function, fluid status, and vascular resistance needs continuous assessment. In addition the EV1000 NI is indicated for use in patients with co-morbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The EV1000 NI noninvasively measures blood pressure and associated hemodynamic parameters.
Product Owner
Name
Edwards Lifesciences LLC
Short Name
Edwards Lifesciences
Address
One Edwards Way, Irvine, CA 92614, UNITED STATES
Registrant
Name
EDWARDS LIFESCIENCES (ASIA) PTE. LTD.
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)
Finger Cuff Large Multi Pack Finger Cuff Medium Multi Pack Finger Cuff Small Multi Pack EV1000 Monitor Databox Mounting Bracket Ethernet Cable EV1000 Ethernet Cable 12 FT (PU – Panel) EV1000 Ethernet Cable 3 FT (PU – Panel) Ethernet Cable EV1000 NI Heart Reference Sensor EV1000 NI Heart Reference Sensor Body Pads Monitor Bracket EV1000 NI Power and Databox Y-Split Power cable EV1000 NI Power Cable 12 FT EV1000 NI Power Cable 3 FT Power Adaptor Mounting Bracket EV1000 NI Patient Monitor Adapter Cable EV1000 NI Pump Unit Roll Stand Table Stand EV1000 NI Pressure Controller Band Multi Pack EV1000 NI Pressure Controller Cuff Connector Cap EV1000 NI Pressure Controller Kit Pressure Controller Cover
Model Identifier(s)
CSCL CSCM CSCS EV1000M EVBB1 EVEC1 EVEC12FT EVEC3FT EVECL EVHRS EVHRSBP EVMB1 EVNIDBAC EVNIPCL12 EVNIPCL3 EVPB1 EVPMAC EVPMP EVRS EVS1 PC2B PC2CCC PC2K PCCVR
About this record

Access comprehensive regulatory information for EDWARDS LIFESCIENCES EV1000 Clinical Platform NI in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0019311 and owned by Edwards Lifesciences LLC. The device was registered on June 09, 2017.

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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