BEUDAMED
    FDA Registration Active 🇦🇹 Austria

    9078 (l13C3fx)

    Reg #: 3029744051 · FEI: 3029744051 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    58
    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
    K223830

    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

    9078 (l13C3fx) UA1339 (Sterile) UA1328 9040 (6C2) 9077 (5P1) UA1326 UA1324 9007 (N20P6) 9081 (18L5s) UA1344 (Sterile) UA1345 (Sterile) UA1239 9052 (20R3) UA2379 Integrated TR Fusion Kit 2300 UA2390 Integrated TP Fusion Kit 2300 UA0673 (Rectosigmoidoscope) 9023 (6C2s) UA1327 UA1325 (Channel Bracket) 9051 (14L3) 9011 (13L4w) 9015 (I14C5I) 9076 (I13C3f) 2300 (bk3000, bk3500, bk5000, bkActiv) 9024 (I12C5b) 9034 (I12C5) UA1336 (Sterile) UA1338 (Sterile) UA1349 9016 (I14C5T) 9019 (E10C4) UA1232 9032 (8L2) 9002 (9C2) 9066 (I12C4f) UA1346 (Sterile) 9096 (Rob12C4) UA1329-S (Sterile) UA1250 9062 (N13C5) 9085 (5C1e) 9018 (E14C4t) 9063 (N11C5s) 9026 (X12C4) 9048 (E14CL4b) UA0671 (Water Standoff) UA1323-S (Sterile) 9009 (X18L5s) UA1282 UA1337 (Sterile) UA1322-S (Sterile) 9070 (18L5) UA1322-S14 (Sterile) 9038 (X14L4) UA1251 UA0672 (Rectosigmoidoscope) 9029 (E13C2) UA1325w (Channel Bracket)

    Establishment Types

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