BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    QTREX Quantum Ltd

    Reg #: 3021562887 · FEI: 3021562887 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

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    Registration Details

    Registration Name
    QTREX Quantum Ltd
    Registration Number
    3021562887
    FEI Number
    3021562887
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2, Ha-Tidhar
    City
    Ra'anana Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K232788

    Owner / Operator

    Firm Name
    QTREX QUANTUM Ltd.
    Operator Number
    10083402
    Address
    2 Ha-Tidhar St.
    City
    Ra'anana
    State
    Central
    Postal Code
    4366504
    Country
    IL
    Correspondent
    Avi Shabtay

    US Agent

    Business Name
    Medicsense USA LLC
    Contact Name
    George Hattub
    Address
    291 Hillside Avenue
    City
    Somerset
    State
    MA
    ZIP
    02726
    Country
    US
    Email
    [email protected]
    Phone
    508 4796116

    Products

    Device Name Product Code
    Control, Pump Speed, Cardiopulmonary Bypass DWA
    Device, Intravascular Catheter Securement KMK
    Accessory Equipment, Cardiopulmonary Bypass KRI

    Proprietary Names

    INSPIRA ART100 Cannula Fixation Device INSPIRA CART

    Establishment Types

    Manufacture Medical Device