BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    GE HEALTHCARE FINLAND OY

    Reg #: 9610105 · FEI: 3002806783 · Expires 2026
    View on FDA
    Products
    47
    Proprietary Names
    215
    Establishment Types
    3
    Classifications
    47

    Registration Details

    Registration Name
    GE HEALTHCARE FINLAND OY
    Registration Number
    9610105
    FEI Number
    3002806783
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    KUORTANEENKATU 2
    City
    HELSINKI Uusimaa
    Country
    FI

    Regulatory Submissions

    510(k) Number
    K101871

    Owner / Operator

    Firm Name
    GE HealthCare Technologies Inc.
    Operator Number
    9912004
    Address
    3000 N. Grandview Blvd
    City
    Waukesha
    State
    WI
    Postal Code
    53188
    Country
    US

    US Agent

    Business Name
    GE HealthCare Technologies, Inc
    Contact Name
    Tracey Holevas
    Address
    3000 N. Grandview BLVD
    City
    Waukesha
    State
    WI
    ZIP
    53188
    Country
    US
    Email
    [email protected]
    Phone
    262 3092157

    Products

    Device Name Product Code
    Oximeter DQA
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    System, Network And Communication, Physiological Monitors MSX
    Monitor, Breathing Frequency BZQ
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Regulator, Pressure, Gas Cylinder CAN
    Computer, Blood-Pressure DSK
    Alarm, Blood-Pressure DSJ
    Detector And Alarm, Arrhythmia DSI
    Cerebral Oximeter QEM
    Electrocardiograph DPS
    Oximeter, Tissue Saturation MUD
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Continuous Measurement Thermometer FLL
    Oximeter, Ear DPZ
    Monitor, St Segment With Alarm MLD
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Computer, Diagnostic, Programmable DQK
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Plethysmograph, Impedance DSB
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Full-Montage Standard Electroencephalograph GWQ
    Monitor, Airway Pressure (Includes Gauge And/Or Alarm) CAP
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG
    Spirometer, Monitoring (W/Wo Alarm) BZK
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Probe, Thermodilution KRB
    Stimulator, Auditory, Evoked Response GWJ
    Computer, Oxygen-Uptake BZL
    Index-Generating Electroencephalograph Software OLW
    Stimulator, Nerve, Peripheral, Electric KOI
    Reduced- Montage Standard Electroencephalograph OMC
    Burst Suppression Detection Software For Electroencephalograph ORT
    Electrode, Cutaneous GXY
    Gas, Calibration (Specified Concentration) BXK
    System, Monitoring, Perinatal HGM
    Cable, Electrode IKD
    Amplifier And Signal Conditioner, Transducer Signal DRQ
    Transmitters And Receivers, Electrocardiograph, Telephone DXH

    Proprietary Names

    TruSignal SpO2 FingerTip Sensor (TS-SA-D) TruSignal SpO2 FingerTip Sensor, GE connector (TS-SA4-GE) Portrait Core Services CSSXB Portrait RR P-RR01 Portrait BCH01 Portrait MMP01 Portrait AAB01 Portrait SpO2 P-W01 Portrait SpO2 P-SP01 Portrait SBT01 Portrait SpO2 P-SE01 Portrait SpO2 P-SA01 Portrait RRP01 Portrait CVAXB Portrait HUBXB Portrait HSWXB Portrait CAU01 MASIMO COMPATIBLE SATURATION MODULE E-MASIMO iVent Circuits Gas exhaust line, white conical, disposable, 2m/6.6 ft, 5514184 Gas exhaust line, white conical and Colder, disposable, 0.18 m/7 in, 5514183 Gas exhaust line, white conical and Colder, disposable, 1 m/3.3 ft, 5514182 E-PP E-PT Calibration Gas Regulator CARESCAPE ONE CARESCAPE DOCK FO CARESCAPE PRES CARESCAPE TEMP CARESCAPE SPO2 CARESCAPE ECG Nellcor saturation module, E-NSATX N-CAiO Airway Gas Option CARESCAPE MONITOR B450 CARESCAPE MONITOR B450-LI CARESCAPE Monitor B450 BEDRAIL HOOK: BEDRAIL HOOK UNIT CARESCAPE B450 BRH CARESCAPE MONITOR B650 CARESCAPE Monitor B650-LI GE ENTROPY SENSOR CARESCAPE RAD CARESCAPE B650 Calibration Gas (755571-HEL) QUICK CAL Calibration Gas (755587) QUICK CAL Calibration Gas Calibration Gas CARESCAPE B450 E-sCAiOVX Gas Sampling Line, Disposable, PVC/PE, 6m/20ft, 2097307-003 D-lite++ Patient Spirometry Set, 3m/10ft, 2104297-002 E-sCAiOE D-Lite+ Spirometry Kit 3m/10ft, 8004382 E-sCAiO Gas Sampling Line, Disposable, PVC/PE, 3m/10ft, 2097307-002 D-fend Pro+ Water Trap, M1200227 SPIROMETRY TUBE, DISPOSABLE, 2M/7FT 890031 D-lite+ sensor, disposable, Adult, 896952 Gas Sampling Line, Disposable, PVC/PE, 2m/7ft, 2097307-001 Pedi-lite+ sensor, disposable, Pediatric, 8001948 SPIROMETRY TUBE, DISPOSABLE, 3M/10FT 884101 Pedi-lite sensor, reusable, Pediatric, 73393 E-sCAiOVE E-sCAiOV D-lite++ Patient Spirometry Set, 2m/7ft, 2104297-001 D-fend Pro Water Trap, M1182629 CARESCAPE Respiratory Modules SPIROMETRY TUBE, DISPOSABLE, 6M/20FT 891191-HEL Pedi-Lite+ Spirometry Kit 3m/10ft, M1032634 E-sCO E-sCOVX Pedi-lite+ Spirometry Kit 2m/7ft, 8002718 E-sCOV D-lite sensor, reusable, Adult, 733910-HEL TruSignal SpO2 Adult Adhesive Wrap Disposable Sensor (TS-AAW-10, TS-AAW-25) TruSignal SpO2 Pediatric Adhesive Wrap Disposable Sensor (TS-PAW-10, TS-PAW-25) TRAM 2001 Module 2006644-001 SpO2 Interconnect cable Nellcor OxiSmart, 2.9m/9.5ft Cardiac Output and SvO2 module, E-COPSv CARDIOSOFT WEB CardioSoft V6.71. Cardiac Testing System CS V6.71 Cardiac Testing System CARDIOSOFT RESTING ECG CS V6.6. Cardiac Testing System CASE CASE V6.6. Cardiac Testing System CARDIOSOFT EKG VIEWER CASE V6.71. Cardiac Testing System CARDIOSOFT CLIENT Cardiosoft V6.72 CASE V6.7 CS V6.71 CARDIOSOFT EXERCISE STRESS TEST CardioSoft V6.73 CS V6.6 Cardiac Testing System CARDIOSOFT SERVER CardioSoft V6.71 Cardiac Testing System CASE V6.6 Cardiac Testing System CASE V6.71 Cardiac Testing System CASE V6.73 E-EEGX N-EEGX Pre-configured EEG Lead Set 2, General Pre-configured EEG Lead Set 1 Ear tips for earphone Pre-configured EEG Lead Set 3, AEP AEP Earphones CASE V7 Cardiac Testing System CardioSoft V7 Cardiac Testing System CONTINUOUS CARDIAC OUTPUT MODULE, E-PiCCO-00 PiCCO Injectate Sensor Cable (M1182448) PiCCO Continuous Cardiac Output Cable (M1154585) Datex-Ohmeda S/5 EEG Module E-EEG Datex-Ohmeda S/5 EEG Headbox AEP Ear Tips for Earphone Set (8001233) EEG Lead set 3 (898052) EEG Lead set 1 (898050) Entropy EasyFit Sensor MAC 600 Resting ECG Analysis System MAC 600 Nellcor OxiMax, 3m/10ft 2021406-002 SpO2 Interconnect cable 2021406-001 SpO2 Interconnect cable Nellcor OxiMax, 1.2m/3.9ft CARESCAPE Canvas Smart Display F2 Frame (F2-01) CARESCAPE Canvas D19 CARESCAPE Canvas 1000 Mini D-fend Water trap Single-width airway module E-miniC TruSignal SpO2 Finger Sensor (TS-F-D) TruSignal SpO2 Sensitive Skin (TS-SE-3) TruSignal SpO2 Ear Sensor (TS-E-D) TruSignal SpO2 Interconnect Cable with GE connector (TS-G3) TruSignal SpO2 attachment accessories (TS-HB-3, TS-RWL-24, TS-RTW-100, TS-SND-3, TS-RWS-24, TS-RWM-24) CARESCAPE B850 E-musb F7-01 Frame F5-01 Frame USB Remote Control CARESCAPE D19KT VER01 Cardiac Output module, E-COP GE ENTROPY SENSOR (REFM1038681) GE ENTROPY CABLE (REF M1050784) MOBILE CARE SOFTWARE MOBILE CARE MOBILE CARE WEB VIEWER WEB VIEWER 2025350-001 SpO2 Interconnect cable, Nellcor OxiMax, 3m/10ft, Corometrics only S/5 COMPACT AIRWAY MODULE D-Fend Water Trap D-Fend+ Water Trap ECG Trunk Cables and Leadwires Trunk Cables (Cardiac Output Cables, Invasive Blood Pressure Cables, Temperature Cables) ECG Adapter Cable NOVII INTERFACE CABLE - GE FECG MECG Cable FECG Cable CLAB ECG Trunk Cable 12-lead AHA 10ft CLAB ECG Trunk Cable 12-lead IEC 10ft NOVII INTERFACE CABLE - GE MECG Novii Cables (NOVII INTERFACE CABLE - GE FECG; NOVII INTERFACE CABLE - GE MECG; NOVII INTERFACE CABLE - GE UA) 4 Leadwire Expansion Cable, grabber, IEC, 74 cm/29 in. NOVII INTERFACE CABLE - GE UA 4 Leadwire Expansion Cable, snap, IEC, 74 cm/29 in. 4 Leadwire Expansion Cable, grabber, IEC, 130 cm/51 in. Cable assembly ECG 3 lead neo IEC long, 3.6 m Cable assembly ECG 3 lead neo AHA short, 1.8 m Cable assembly ECG 3 lead neo AHA long, 3.6 m 4 Leadwire Expansion Cable, snap, IEC, 130 cm/51 in. Cable assembly ECG 3 lead neo IEC short, 1.8 m 4 Leadwire Expansion Cable, snap, AHA, 130 cm/51 in. 4 Leadwire Expansion Cable, grabber, AHA, 74 cm/29 in. 4 Leadwire Expansion Cable, snap, AHA, 74 cm/29 in. 4 Leadwire Expansion Cable, grabber, AHA, 130 cm/51 in. TruSignal SpO2 PediTip Sensor, GE connector (TS-SP3-GE) TruSignal SpO2 PediTip Sensor (TS-SP-D) Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) Portrait™ Central Viewer Application (Portrait CVA01) Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SE01) Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01) Portrait™ Sensor Battery (Portrait SBT01) Portrait™ Core Services (Portrait CSS01) Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-W01) Portrait™ Bedside Charger (Portrait BCH01) Portrait™ Mobile Patient Monitor (Portrait HUB01) Portrait™ Clinical Alarming Unit (Portrait CAU01) Portrait™ Mobile Patient Monitor Pouch (Portrait MMP01) Portrait™ RR Electrode Patch (Portrait RRP01) Portrait™ Wearable Respiration Rate Sensor (Portrait RR P-RR01) PSM MODULE BUS ADAPTER SHORT PSM POLE MOUNT LONG PSM POLE MOUNT DATEX-OHMEDA S/5 E-PSM(P) MODULE TruSignal SpO2 Finger Sensor, GE connector (TS-F4-GE) TruSignal SpO2 Ear Sensor, GE connector (TS-E4-GE) NEUROMUSCULAR TRANSMISSION MODULE, E-NMT DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT NMT Regional Block Adapter 0.5m/1.5ft NMT MechanoSensor 0.3m/1ft NMT ElectroSensor 0.3m/1ft NMT Pediatric MechanoSensor 0.3m/1ft NMT Sensor Cable 3.3m/11ft NMT Electrodes, Solid Gel, Ag/AgCl, 30/pkg MAC 2000 Entropy Module E-ENTROPY-01 DATEX-OHMEDA S/5 BIS MODULE E-BIS F5 Frame F7 Frame CARESCAPE MONITOR B850 CARESCAPE D19KT CARESCAPE MONITOR B850-LI

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Repack or Relabel Medical Device