BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    HADECO, INC.

    Reg #: 9611033 · FEI: 3002807138 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    HADECO, INC.
    Registration Number
    9611033
    FEI Number
    3002807138
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2-7-11 ARIMA, MIYAMAE-KU
    City
    KAWASAKI Kanagawa
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K153762

    Owner / Operator

    Firm Name
    Hadeco, Inc.
    Operator Number
    8030313
    Address
    2-7-11 Arima, Miyamae-ku
    City
    Kawasaki
    State
    Kanagawa
    Postal Code
    216-0003
    Country
    JP
    Correspondent
    Takuji Hakamada

    US Agent

    Business Name
    KOVEN TECHNOLOGY, INC.
    Contact Name
    HEATHER BELL
    Address
    477 N. Lindbergh Blvd., SUITE 220
    City
    ST. LOUIS
    State
    MO
    ZIP
    63141
    Country
    US
    Email
    [email protected]
    Phone
    314 5422101

    Products

    Device Name Product Code
    Transducer, Ultrasonic JOP
    Flowmeter, Blood, Cardiovascular DPW
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Monitor, Ultrasonic, Nonfetal JAF
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Doppler, Ultrasonic IYN

    Proprietary Names

    Smardop XT6 HD-307 Smartdop 30EX Smartdop XT SmartVLink software BiDop 3 CW Doppler probes ES100VX MiniDoppler PW Doppler probes Smartdop 45 Bidop 7 MiniDoppler ES100X

    Establishment Types

    Manufacture Medical Device