BEUDAMED
    FDA Registration Active 🇦🇹 Austria

    Samsung MINIER7

    Reg #: 3029744051 · FEI: 3029744051 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    22
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    LYSIS HEALTHCARE GMBH
    Registration Number
    3029744051
    FEI Number
    3029744051
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Grillweg 24
    City
    Graz Steiermark
    Country
    AT

    Regulatory Submissions

    510(k) Number
    K211945

    Owner / Operator

    Firm Name
    Lysis Healthcare GmbH
    Operator Number
    10093389
    Address
    Grillweg 24
    City
    Graz
    State
    Steiermark
    Postal Code
    8053
    Country
    AT
    Correspondent
    Sebastian Tautscher

    US Agent

    Business Name
    Midwest Imaging Corp.
    Contact Name
    Robert Grzeskowiak
    Address
    920 Hemsath Rd Ste 102
    City
    Saint Charles
    State
    MO
    ZIP
    63303
    Country
    US
    Email
    [email protected]
    Phone
    636 9250030

    Products

    Device Name Product Code
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX

    Proprietary Names

    Samsung MINIER7 Samsung LA3-22AI Samsung CA4-10M Samsung LA4-18AD Samsung LA2-9S Samsung CA1-7S Samsung PA1-5A Samsung EA2-11AR Samsung EA2-11AV Samsung LA4-18A Samsung PA4-12B Samsung DP2B Samsung CW60 Samsung MMPT3-7 Samsung EV2-10A Samsung LA3-16AI Samsung CA1-7A Samsung LA2-14A Samsung CA3-10A Samsung PA3-8B Samsung V8 Samsung CV1-8A

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device