BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    WS-140P

    Reg #: 3016852448 · FEI: 3016852448 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Nihon Kohden Corporation - Eastern Japan Logistics Center
    Registration Number
    3016852448
    FEI Number
    3016852448
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1-1 Nishi-Inter, 2-Chome
    City
    Sakado City Saitama
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K223567

    Owner / Operator

    Firm Name
    NIHON KOHDEN CORP.
    Operator Number
    8030227
    Address
    1-31-4 NISHIOCHIAI, SHINJUKU-KU
    City
    TOKYO
    State
    JP-13
    Postal Code
    161-8560
    Country
    JP

    US Agent

    Business Name
    Nihon Kohden America, LLC
    Contact Name
    Charlemagne Chua
    Address
    15353 Barranca Parkway
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    949 3303964

    Products

    Device Name Product Code
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Amplifier And Signal Conditioner, Transducer Signal DRQ
    System, Network And Communication, Physiological Monitors MSX

    Proprietary Names

    WS-140P DH-140P YS-122P8 YS-122P7 CNS-2101 Central Monitor KG-210P DM-140P DZ-140P

    Establishment Types

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