BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    CARESCAPE ONE

    Reg #: 9610105 · FEI: 3002806783 · Expires 2025
    View on FDA
    Products
    16
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    16

    Registration Details

    Registration Name
    GE HEALTHCARE FINLAND OY
    Registration Number
    9610105
    FEI Number
    3002806783
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    KUORTANEENKATU 2
    City
    HELSINKI Uusimaa
    Country
    FI

    Regulatory Submissions

    510(k) Number
    K213234

    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
    Cerebral Oximeter QEM
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Detector And Alarm, Arrhythmia DSI
    Oximeter DQA
    Alarm, Blood-Pressure DSJ
    Electrocardiograph DPS
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Oximeter, Tissue Saturation MUD
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Oximeter, Ear DPZ
    Continuous Measurement Thermometer FLL
    Monitor, St Segment With Alarm MLD
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Monitor, Breathing Frequency BZQ
    Computer, Diagnostic, Programmable DQK
    Computer, Blood-Pressure DSK

    Proprietary Names

    CARESCAPE ONE CARESCAPE ECG CARESCAPE TEMP CARESCAPE SPO2 CARESCAPE PRES CARESCAPE DOCK FO

    Establishment Types

    Manufacture Medical Device