BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Fukuda Denshi Fine Tech Sendai Co. Ltd.

    Reg #: 3010663777 · FEI: 3010663777 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Fukuda Denshi Fine Tech Sendai Co. Ltd.
    Registration Number
    3010663777
    FEI Number
    3010663777
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5 Technohills, Taiwa-cho
    City
    Kurokawa-gun Miyagi
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K110920

    Owner / Operator

    Firm Name
    FUKUDA DENSHI CO., LTD.
    Operator Number
    9028352
    Address
    3-39-4, HONGO, BUNKYO-KO, --
    City
    TOKYO
    State
    JP-NOTA
    Postal Code
    113
    Country
    JP
    Correspondent
    Doug W Blakely

    US Agent

    Business Name
    Fukuda Denshi USA, Inc.
    Contact Name
    Doug Blakely
    Address
    17725 Ne 65th St Ste C
    City
    Redmond
    State
    WA
    ZIP
    98052
    Country
    US
    Email
    [email protected]
    Phone
    210 2404521

    Products

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

    Proprietary Names

    Fukuda Denshi UltraSound UF-760AG Sigma 5000 Series Ultrasound FD DS-5000 Series Telemetry Fukuda Denshi UF-Series Ultrasound FD UF-5800 Ultrasound FD UF-750 3D Ultrasound Fukuda Denshi UF-800 Series Ultrasound Fukuda Denshi US-750 XT Ultrasound

    Establishment Types

    Manufacture Medical Device