BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    SUMITOMO MITSUI FINANCE AND LEASING CO., LTD.

    Reg #: 3012939903 · FEI: 3012939903 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    11

    Registration Details

    Registration Name
    SUMITOMO MITSUI FINANCE AND LEASING CO., LTD.
    Registration Number
    3012939903
    FEI Number
    3012939903
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1-3-2, MARUNOUCHI,, CHIYODA-KU,
    City
    TOKYO
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K061817
    PMA Number
    P080003

    Owner / Operator

    Firm Name
    SUMITOMO MITSUI FINANCE AND LEASING CO., LTD.
    Operator Number
    10061600
    Address
    2-1-1, HITOTSUBASHI, CHIYODA-KU,
    City
    TOKYO
    State
    JP-13
    Postal Code
    100-8287
    Country
    JP
    Correspondent
    KOJI HARADA

    US Agent

    Business Name
    SUMITOMO MITSUI FINANCE AND LEASING CO., LTD., NY BRANCH
    Contact Name
    SHOTA KAWASHIMA
    Address
    8TH FLOOR, 666 THIRD AVENUE
    City
    New York
    State
    NY
    ZIP
    10017
    Country
    US
    Email
    [email protected]
    Phone
    917 5423500

    Products

    Device Name Product Code
    System, X-Ray, Tomography, Computed JAK
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Digital Breast Tomosynthesis OTE
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Interventional Fluoroscopic X-Ray System OWB
    System, X-Ray, Angiographic IZI
    System, Nuclear Magnetic Resonance Spectroscopic LNI
    System, Nuclear Magnetic Resonance Imaging LNH

    Establishment Types

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