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Edwards Lifesciences HemoSphere Advanced Monitor - HSA Registration DE0500952

Access comprehensive regulatory information for Edwards Lifesciences HemoSphere Advanced 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 DE0500952 and owned by Edwards Lifesciences LLC. The device was registered on December 11, 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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CLASS C
DE0500952
Edwards Lifesciences HemoSphere Advanced Monitor
HSA Registration Number: DE0500952
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Product Description

The HemoSphere advanced monitoring platform is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. The HemoSphere advanced monitoring platform is intended for use with compatible Edwards Swan-Ganz and oximetry catheters, FloTrac, Acumen IQ, TruWave DPT, ForeSight Elite sensors, ClearSight finger cuffs and Acumen IQ finger cuffs.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0500952
Registration Date
December 11, 2017
Change Notification Approval Date
January 21, 2025
Retention Due Date
December 10, 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
Model Information
Model Name(s)
Patient CCO cable Acumen IQ Finger Cuff Large Acumen IQ Finger Cuff Medium Acumen IQ Finger Cuff Small Acumen IQ Sensor Acumen IQ Sensor Acumen IQ Sensor Acumen IQ Sensor Acumen IQ Sensor Acumen IQ Sensor Acumen IQ Sensor Acumen IQ Sensor Acumen IQ Sensor Clearsight Finger Cuff Large Multi Pack Clearsight Finger Cuff Medium Multi Pack Clearsight Finger Cuff Small Multi Pack Heart Reference Sensor ForeSight Large Sensor ForeSight Jr Medium Sensor ForeSight Jr Non-Adhesive Small Sensor ForeSight Jr Small Sensor HemoSphere advanced monitor HemoSphere battery pack HemoSphere ClearSight Module HemoSphere Pressure-Out Cable HemoSphere expansion module ForeSight Oximeter Cable HemoSphere oximetry cable Pressure Controller Kit HemoSphere Pressure Cable HemoSphere advanced monitor roll stand HemoSphere Swan-Ganz module HemoSphere Technology Module Pressure Controller Kit
Model Identifier(s)
70CC2 AIQCL AIQCM AIQCS AIQS6 AIQS65 AIQS6R AIQS6S AIQS8 AIQS85 AIQS8C503 AIQS8R AIQS8S CSCL CSCM CSCS EVHRS FSESL FSESM FSESNS FSESS HEM1 HEMBAT10 HEMCSM10 HEMDPT1000 HEMEXPM10 HEMFSM10 HEMOXSC100 HEMPC2K HEMPSC100 HEMRLSTD1000 HEMSGM10 HEMTOM10 PC2K