BEUDAMED
    FDA Registration Active 🇦🇹 Austria

    BK Medical 8811

    Reg #: 3029744051 · FEI: 3029744051 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    42
    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
    K132335

    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
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    BK Medical 8811 BK Medical UA1324 BK Medical UA1250 BK Medical UA1251 BK Medical UA1323-S (Sterile) BK Medical 8815 BK Medical UA1345 (Sterile) BK Medical UA1328 BK Medical 8823 BK Medical UA1327 BK Medical 8862 BK Medical 1202 (Flex Focus) BK Medical UA1282 BK Medical UA1326 BK Medical 8818 BK Medical UA1257S17E (Sterile) BK Medical UA1322-S14 (Sterile) BK Medical 8816 BK Medical 8826 BK Medical 8830 BK Medical 8666-RF BK Medical UA1329-S (Sterile) BK Medical UA1346 (Sterile) BK Medical 8824 BK Medical 8863 BK Medical 8838 BK Medical UA1256 BK Medical 8809 BK Medical UA1336 (Sterile) BK Medical 8820e BK Medical 8808e BK Medical 8670 BK Medical UA1337 (Sterile) BK Medical 2052 BK Medical 8667 BK Medical UA1322-S (Sterile) BK Medical UA1257-S14 (Sterile) BK Medical 8819 BK Medical 8870 BK Medical UA1239 BK Medical UA1232 BK Medical 8848

    Establishment Types

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