BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Nihon Kohden Tomioka Corporation

    Reg #: 3007962724 · FEI: 3007962724 · Expires 2026
    View on FDA
    Products
    20
    Proprietary Names
    185
    Establishment Types
    2
    Classifications
    20

    Registration Details

    Registration Name
    Nihon Kohden Tomioka Corporation
    Registration Number
    3007962724
    FEI Number
    3007962724
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    486 Nanokaichi
    City
    Gunma Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K071969

    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
    Connector, Airway (Extension) BZA
    Stimulator, Electrical, Evoked Response GWF
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Standard Polysomnograph With Electroencephalograph OLV
    Full-Montage Standard Electroencephalograph GWQ
    Electrode, Cortical GYC
    Stimulator, Nerve, Peripheral, Electric KOI
    Stimulator, Photic, Evoked Response GWE
    Stimulator, Auditory, Evoked Response GWJ
    Device, Galvanic Skin Response Measurement GZO
    Electromyograph, Diagnostic IKN
    Device, Nerve Conduction Velocity Measurement JXE

    Proprietary Names

    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 BM-412B JW-120B AG-920RA AG-920RA Mulitgas Unit NK-NEUROFAX-R TL-062S JE-213A A/TRACKTRANS JE-120A-24 NK-CENTRAL-150 QP-160R-10 TG-921T3 QI-123A A/RELAYBOX TL-274T JE-212A A/PHOTIC-3 A/SONYCART JE-208A JE-225AK NE-134A NK-CENTRAL-SW DI-120A EEG-1250A QP-110AK QI-124A AAA-17041 NK-REVSUITE-10 QI-122A A/POUCH-JE922 QD-120A NIHON KOHDEN EEG-1200A SERIES NEUROFAX EEG-1260A QI-120A NE-114A BC-112B JE-210A JE-120A-22 NK-REVSUITE-MU JE-915A KC-001A JE-921A QP-160AK JE-209A A/NIH8000 A/SONYCART-3 JE-214A YL-104A A/QP-160A-VS-10 KH-122A A/AIRPHOTICKIT KH-121A JE-922A KE-122A TL-271T EEG-1200A TL-201T NK-LS-901AJ NK-XPPSGRD-SFF A/DCIN1200 A/QP-160A-VS-25 JE-120A-23 JL-550T1 TL-052S EEG-1200A-T NK-REVSUITE-5 A/ABC300-11MED YL-103A A/NWB-HL7NIS NC-143E EEG-1200AA NE-113A JE-207A A/GCXCART A/NWB-HL7CS JE-226AK NE-311A A/POUCHTRIFOLD LS-703A TL-220T JE-227AK EEG-1200A-RAID QP-101BK MEE-1000A NEUROMASTER PE-210A Nihon Kohden PE-210AK Switch Box for EEG-1200A TL-631T1 JS-210B JS-201B TL-260T JB-210B BM-121B YG-135T MEE-2000A-DT DC-200B Neural Function Measuring System MEE-2000 YB-201B TL-631T3 Neuromaster G1 MEE-2000 JS-202B BM-701B YE-103J TL-051S JB-316B JB-232B JS-204B LS-102J YG-122T TL-061S YG-125T VD-403B MEE-2000A-LT DR-531B-14 JS-203B NMT Smart Pod Smart Cable NMT Pod, with EMG Support TOF Smart Pod TOF Pod TOF electrodes Life Scope BSM 3000 Series Bedside Monitors EMG electrodes JW-201P Main cable NMT Pod NMT electrodes AF-201P NMT module Disposable electrodes NM-345Y Disposable electrodes NMT Smart Cable TOF Pod DH-101P Holder Life Scope BSM 6000 Series Bedside Monitors MEB-2300A Neuropack Evoked Potential & EMG Measuring System QP-946BK SC-900B KH-960A YZ-0172 RY-441B DI-960B A/NIH9000 KD-019A BM-001B MEB-9400A-DT QP-947BK KH-001A JB-910B QP-948BK NE-430B RY-960B JB-962B YZ-004A4 JB-964B MEB-9400A NE-132B TL-273T NEUROFAX, MODELS EEG-1100A with EEG-9100A AND JUNCTION BOX FUNCTIONS JE-215AK LS-703AA JE-217AK LS-901AJ YZ-0226 JE-425A JE-216AK QP-150AK JE-912AK EEG-9100A KE-910A EEG-9200A Data Acquisition Unit Life Scope® BSM 6000 Series Bedside Monitoring Systems Life Scope® CSM-1901 Bedside Monitoring Systems AY Input Unit Series Life Scope® PT BSM-1700 Series

    Establishment Types

    Manufacture Medical Device Remanufacture Medical Device