BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FUJIFILM Healthcare Americas Corporation

    Reg #: 1000513161 · FEI: 1000513161 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    FUJIFILM Healthcare Americas Corporation
    Registration Number
    1000513161
    FEI Number
    1000513161
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    81 Hartwell Ave Ste 100
    City
    Lexington
    State
    MA
    ZIP
    02421
    Country
    US

    Regulatory Submissions

    510(k) Number
    K122537

    Owner / Operator

    Firm Name
    FUJIFILM CORPORATION
    Operator Number
    8031568
    Address
    26-30, Nishiazabu 2-chome
    City
    MINATO-KU
    State
    Tokyo
    Postal Code
    106-8620
    Country
    JP

    Products

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

    Proprietary Names

    UST-9150 S12BP4 Neurosurgery Probe C9150LA FUJIFILM Stiffening Wire Device (SW-2000)

    Establishment Types

    Manufacture Medical Device