BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    Proton B.V.

    Reg #: 3012987001 · FEI: 3012987001 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    44
    Establishment Types
    2
    Classifications
    4

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    Registration Details

    Registration Name
    Proton B.V.
    Registration Number
    3012987001
    FEI Number
    3012987001
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Dr. Nolenslaan 157/J
    City
    GM Sittard Limburg
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K253288

    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 5 Pkwy
    City
    Fishers
    State
    IN
    ZIP
    46037
    Country
    US
    Email
    [email protected]
    Phone
    317 8136013

    Products

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

    Proprietary Names

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

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device