BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    ESAOTE S.P.A.

    Reg #: 3012981490 · FEI: 3012981490 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    44
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    ESAOTE S.P.A.
    Registration Number
    3012981490
    FEI Number
    3012981490
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Via degli Olmi 11
    City
    Sesto Fiorentino Firenze
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K241671

    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
    Correspondent
    Esaote - Regulatory

    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
    Automated Radiological Image Processing Software QIH
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    MyLabE85 MyLabE80 AU6 7348 7410 model MyLabSigma MyLabSigma elite 6400 Model MyLabX7 MyLabX6 MyLabSix CrystaLine 6425 ML30 (7300 & 7340) ML5 MyLab40 Ultrasound System 6420 MyLabSix MyLabOmega 7400 model MyLabOmega eXP 6450 Model MyLabX8 eXP MyLabX8 MyLab 9 eXP 6440 Ultrasound System MyLab 9 MyLabX9 MyLabX90 MyLabA70 MyLabA50 6430 US System MyLabX75 MyLabX5 6250 Ultrasound System 6200 Ultrasound System MyLabOne MyLabClass C 6250 MyLabTwice 6200 MyLabEight MyLabEight eXP MyLabC25 MyLabC30 MYLABALPHA MYLABSEVEN MyLabSeven 7400 MyLabAlpha 6400 MylabGamma 7410

    Establishment Types

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