BEUDAMED
    FDA Registration Active 🇹🇭 Thailand

    TL-271T3

    Reg #: 3014633893 · FEI: 3014633893 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SUMIDA ELECTRIC (THAILAND) CO.,LTD
    Registration Number
    3014633893
    FEI Number
    3014633893
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    129/50, Mu 3, Wang Chula Sub-district
    City
    Wang Noi Phra Nakhon Si Ayutthaya
    Country
    TH

    Regulatory Submissions

    510(k) Number
    K151080

    Owner / Operator

    Firm Name
    Sumida Electric Co., Ltd.
    Operator Number
    10058463
    Address
    Kawasaki Isago Building 2F, 1-2-4,Isago, Kawasaki-ku
    City
    Kawasaki City
    State
    Kanagawa
    Postal Code
    210-0006
    Country
    JP
    Correspondent
    Kenichi Fujishima

    US Agent

    Business Name
    NIHON KOHDEN AMERICA, INC.
    Contact Name
    Sandra Gadeyne
    Address
    15353 Barranca Pkwy, --
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    949 2687708

    Products

    Device Name Product Code
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX

    Proprietary Names

    TL-271T3

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)