BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    FUKUDA DENSHI CO., LTD.

    Reg #: 9611031 · FEI: 3002807019 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    FUKUDA DENSHI CO., LTD.
    Registration Number
    9611031
    FEI Number
    3002807019
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3-39-4, HONGO,
    City
    BUNKYO-KU Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K050363

    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
    Detector And Alarm, Arrhythmia DSI
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Oximeter DQA

    Proprietary Names

    FD DS-5000 Series Telemetry FD DS-5700 CS FD DS-7100 Series Patient Monitor FD DS-7141 Series Monitor Fukuda Denshi HG Series Pulse Oximeter Sigma 5000 Series Ultrasound FD UF-750 3D Ultrasound FD DS-5000 CS

    Establishment Types

    Manufacture Medical Device