BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Nihon Kohden Tomioka Corporation Nihon Kohden Kawamoto Production Center

    Reg #: 3007481893 · FEI: 3007481893 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    47
    Establishment Types
    1
    Classifications
    9

    Registration Details

    Registration Name
    Nihon Kohden Tomioka Corporation Nihon Kohden Kawamoto Production Center
    Registration Number
    3007481893
    FEI Number
    3007481893
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2909-63 Shirakusadai
    City
    Fukaya-Shi Saitama
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K860210

    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 Pkwy, --
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    949 3303964

    Products

    Device Name Product Code
    Media, Electroconductive GYB
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Connector, Airway (Extension) BZA
    Electrode, Needle, Diagnostic Electromyograph IKT
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Amplifier And Signal Conditioner, Transducer Signal DRQ
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    System, Network And Communication, Physiological Monitors MSX
    Laryngoscope, Rigid CCW

    Proprietary Names

    ELEFIX ELECTRODE CREAM TG-980P TG-970P TG-980P1 TG-920P YG-135T YG-125T YG-220T cap-ONE Nasal Adapter, Pediatric, w/ Oxygen tube YG-221T YG-231T YG-230T cap-ONE Nasal Adapter, Pediatric cap-ONE Nasal Adapter, Adult, w/ Oxygen tube cap-ONE Nasal Adapter, Adult YG-213T YG-235T YG-214T YG-213T-A1 YG-225T YG-211T TG-980P CO2 Sensor Kit with Smart Connector TG-980P1 CO2 Sensor Kit with Smart Connector TG-980P CO2 Sensor Kit TG-980P1 CO2 Sensor Kit with Smart Cable TG-980P1 CO2 Sensor Kit TG-980P CO2 Sensor Kit with Smart Cable YG-122T EMG ELECTRODES AND EXTENSION CORDS CNS-2101 Central Monitor DM-140P DZ-140P YS-122P7 YS-122P8 DH-140P WS-140P KG-210P P-Blade ITL-LL Airway Scope AWS-S200 P-Blade ITL-NL P-Blade ITL-PL P-Blade ITL-SL P-Blade ITL-TL TG-900P YG-101T TG-101T JG-900P

    Establishment Types

    Manufacture Medical Device