BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    SIEMENS BIOGRAPH 16

    Reg #: 3017772876 · FEI: 3017772876 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    NIPPON EVERX K.K.
    Registration Number
    3017772876
    FEI Number
    3017772876
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    902 Pearl Building, 8-15 Miyamae-cho, Kawasaki-ku,
    City
    Kawasaki-shi Kanagawa
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K083852

    Owner / Operator

    Firm Name
    Nippon Everx K.K.
    Operator Number
    10078305
    Address
    902 Pearl Building, 8-15 Miyamae-cho, Kawasaki-ku,
    City
    Kawasaki-shi
    State
    Kanagawa
    Postal Code
    210-0012
    Country
    JP
    Correspondent
    Ravinder Singh

    US Agent

    Business Name
    EverX USA LLC
    Contact Name
    Hamish Dunn
    Address
    2410 LA MIRADA DRIVE
    City
    Vista
    State
    CA
    ZIP
    92081
    Country
    US
    Email
    [email protected]
    Phone
    760 4297019

    Products

    Device Name Product Code
    System, X-Ray, Tomography, Computed JAK
    System, Tomography, Computed, Emission KPS

    Proprietary Names

    SIEMENS BIOGRAPH 16

    Establishment Types

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