BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    MyLabX8

    Reg #: 9611125 · FEI: 3002806925 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    ESAOTE S.P.A.
    Registration Number
    9611125
    FEI Number
    3002806925
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    VIA DI CACIOLLE 15
    City
    FLORENCE Firenze
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K192157

    Owner / Operator

    Firm Name
    ESAOTE S.P.A.
    Operator Number
    8021005
    Address
    via Enrico Melen 77
    City
    Genoa
    State
    Genova
    Postal Code
    16152
    Country
    IT

    US Agent

    Business Name
    Esaote North America, Inc
    Contact Name
    Kim Akers
    Address
    11907 EXIT FIVE PARKWAY
    City
    Fishers
    State
    IN
    ZIP
    46037
    Country
    US
    Email
    [email protected]
    Phone
    317 8136013

    Products

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

    Proprietary Names

    MyLabX8 MyLabX8 eXP 6450 Model

    Establishment Types

    Manufacture Medical Device