BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    FibriCheck

    Reg #: 3015976873 · FEI: 3015976873 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    QOMPIUM NV
    Registration Number
    3015976873
    FEI Number
    3015976873
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Kempische Steenweg 303/27
    City
    Hasselt Limburg
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K232804

    Owner / Operator

    Firm Name
    Qompium NV
    Operator Number
    10061438
    Address
    Kempische Steenweg 303/27
    City
    Hasselt
    State
    Limburg
    Postal Code
    3500
    Country
    BE

    US Agent

    Business Name
    VP US Operations Qserve Group US
    Contact Name
    Mindy McCann
    Address
    350 S Main St Suitem309
    City
    Doylestown
    State
    PA
    ZIP
    18901
    Country
    US
    Email
    [email protected]
    Phone
    424 2718169

    Products

    Device Name Product Code
    Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate QME
    Transmitters And Receivers, Electrocardiograph, Telephone DXH

    Proprietary Names

    FibriCheck

    Establishment Types

    Manufacture Medical Device