BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    NIHON KOHDEN TOMIOKA PRODUCTION CENTER

    Reg #: 8030229 · FEI: 3002807739 · Expires 2026
    View on FDA
    Products
    27
    Proprietary Names
    522
    Establishment Types
    1
    Classifications
    27

    Registration Details

    Registration Name
    NIHON KOHDEN TOMIOKA PRODUCTION CENTER
    Registration Number
    8030229
    FEI Number
    3002807739
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1-1 Tajino
    City
    TOMIOKA-SHI Gunma
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K110594

    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
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Device, Galvanic Skin Response Measurement GZO
    Device, Nerve Conduction Velocity Measurement JXE
    Stimulator, Auditory, Evoked Response GWJ
    Stimulator, Electrical, Evoked Response GWF
    Electromyograph, Diagnostic IKN
    Full-Montage Standard Electroencephalograph GWQ
    Stimulator, Photic, Evoked Response GWE
    Connector, Airway (Extension) BZA
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Stimulator, Nerve, Peripheral, Electric KOI
    Standard Polysomnograph With Electroencephalograph OLV
    Amplitude-Integrated Electroencephalograph OMA
    Reduced- Montage Standard Electroencephalograph OMC
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Detector And Alarm, Arrhythmia DSI
    Endoscopic Bite Block MNK
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Electrocardiograph DPS
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Burst Suppression Detection Software For Electroencephalograph ORT
    Automatic Event Detection Software For Full-Montage Electroencephalograph OMB
    Electrode, Cutaneous GXY
    Medical Device Data System OUG
    Electrode, Cortical GYC
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    Media, Electroconductive GYB

    Proprietary Names

    GF-210R Multi-Gas Module for Nihon Kohden Bedside Monitors QP-946BK BM-701B SC-900B DR-531B-14 KH-960A YZ-0172 RY-441B YE-103J DI-960B A/NIH9000 KD-019A BM-001B MEB-9400A-DT NE-134A QP-947BK LS-102J KH-001A JB-910B QP-948BK NE-430B RY-960B A/NWB-HL7CS JB-962B YZ-004A4 JB-964B MEB-9400A NE-132B 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 IF-961P YP-715T QF-909P IF-963P QS-028PA YJ-910P IF-956P IF-951P JP-910P YS-096P2 IF-935P IF-942P JL-900P JL-639P QF-903P YS-096P3 JL-632P IF-950P TL-631T3 DZ-170P JP-900P TL-201T JL-631P IF-920P YP-710T IF-930P IF-913P TL-052S IF-912P IF-927P IF-946P TL-274T QI-632P YG-111T TG-101T QI-672P YP-711T QM-600P TL-272T3 IF-932P QI-600P QI-430PA DH-220P JG-900P IF-957P JL-500P1 JP-920P IF-19004 JO-900P JT-900P YN-901P TL-271T IF-916P QP-038P TL-273T3 TL-220T TR-900P YJ-920P YN-900P JT-950P A/FQW-50-2-100 YP-713T QI-373P YG-001P IF-939P IF-914P QI-610PA IF-922P QF-901P TG-900P QI-634P BR-903PA TL-062S AA-674P IF-917P JL-630P TL-274T3 IF-943P IF-955P BR-906PA YJ-671P TL-271T3 YG-122T QS-065PA SC-170R YP-712T QS-042P QI-631P YN-990P IF-954P YS-096P5 QF-907P QF-921P MU-651RA QI-671P QF-904P JC-906PA QF-911P YN-921P YS-63015 DH-170P YS-096P6 SB-671P JA-694PA BJ-900PA IF-919P QF-801P YN-920P IF-923P CD-237P QI-320PA YP-714T MU-631RA WS-671P IF-948P QF-908P QF-902P YJ-672P IF-928P SB-170P RY-910PA YG-101T NK-ASPECT-BISX MU-671RA IF-937P JL-650P IF-944P TL-535U IF-925P IF-958P Nihon Kohden JE-120A Multi Electrode Junction Box 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 JW-124A DH-120A JL-570T ZB-120A KC-120A JE-922A YC-120A JW-126A JW-122A JW-125A MU-120A SB-121A SB-120A JE-125AK JW-121A JW-120A JE-225AK JW-123A Nihon Kohden AE-918P Neuro Unit BM-412B JW-120B QP-039P Afib Detection Program CARBON DIOXIDE MONITOR, MODEL OLG-2800A TL-061S TG-980P DH-172P YS-100P7 YG-272T DH-171P TG-970P TL-272T JL-030U2 TL-273T KC-170P TL-631T1 HIT-100 JL-030U1 YG-242T YG-232T YG-227T TL-051S TG-920P YG-282T DH-380P BSM-2301A NK-ASAAPPLIANCE BSM-2351A BR-916PA NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR BSM-2354A BR-913PA CRC-6803-7450 CRC-6803-3464 CRC-6803-7480 CRC-6804-7480 SB-901D YZ-041H2 KD-105D BA-903D ECG-1350A ECG-1250A SERIES CARDIOFAX ECG-1250A NKB-301V DI-015D ECG-1350A SERIES CARDIOFAX KH-100D DI-014D A/NTX-DISP ZM-530PA ZM-521PA ZM-541PA ZS-940PA YP-504P ZM-520PA YP-944P A/NTX2-POUCH ZM-531PA ZM-540PA YP-503P YP-943P YG-135T YG-125T MEB-2300A Neuropack Evoked Potential & EMG Measuring System Life Scope® G7H Nihon Kohden Life Scope® G7 Bedside Monitoring System Life Scope® G5L, Life Scope® G5-HD DM-150P Stand (for CU-171R, CU-172R) Life Scope® G7 H Life Scope® G5 Plus DH-157P Adapter KG-150P Wall mount kit (for CU-171R, CU-172R) QI-152P Side option board for CU-152R Life Scope® G5 Lite Life Scope® G7 with (DAU) Data Acquisition Module DH-190P Unit holder CU-171R Core unit Life Scope® G5 Max G5 All-in-one Patient Monitor Life Scope® G7 High Acuity Monitor Nihon Kohden Life Scope® G5 Bedside Monitoring System Life Scope® G5L Life Scope® G5-HD YS-116P0 SSD Expansion Board QI-152P Side option board Life Scope® G5 X QI-151P Rear option board for CU-151R/CU-152R SB-950P Battery Pack DZ-150P Handle (for CU-151R, CU-152R) Life Scope® G5 Life Scope® G5 H DH-159P Unit holder CU-152R Core unit Life Scope® G5 Min WS-171P Recorder Unit CU-171R/CU-172R KC-150P Cart (for CU-171R, CU-172R) DH-150P Unit holder JA-170P Data Acquisition Unit QM-151P SD Card CU-172R Core unit DH-151P Adapter SB-970P Battery Pack DH-154P IF holder QS-127PA Software Kit DH-158P GF holder CU-151R Core unit AA-174P Multi Amp Unit QS-116PA Software Kit QI-171P Rear option board CU-171R/CU-172R WS-151P Recorder Unit DH-153P Recorder holder DH-152P Channel adapter DH-156P Unit holder DH-155P Holder QP-160AK JC-103TA YN-121T YN-101T 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 PSG-1100 Sleep Diagnostic System JE-921A TG-921T3 Nihon Kohden TG-970 CO2 Sensor Kit NK-NEUROFAX-R JE-213A A/TRACKTRANS JE-120A-24 NK-CENTRAL-150 QP-160R-10 QI-123A A/RELAYBOX JE-212A A/PHOTIC-3 A/SONYCART JE-208A 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-209A A/NIH8000 A/SONYCART-3 JE-214A YL-104A A/QP-160A-VS-10 KH-122A A/AIRPHOTICKIT KH-121A KE-122A EEG-1200A NK-LS-901AJ NK-XPPSGRD-SFF A/DCIN1200 A/QP-160A-VS-25 JE-120A-23 JL-550T1 EEG-1200A-T NK-REVSUITE-5 A/ABC300-11MED YL-103A A/NWB-HL7NIS NC-143E EEG-1200AA NE-113A JE-207A A/GCXCART JE-226AK NE-311A A/POUCHTRIFOLD LS-703A JE-227AK EEG-1200A-RAID EEG-1100A Switchbox JE-425A JE-215AK LS-703AA JE-217AK JE-912AK JE-216AK NE-090S1 ZElectrode NE-091S7 Disposable Electrode AE-120A EEG Heatset JL-951T3 Medical Device Gateway Communication Cable MDI-1000 IF-949P Nihon Kohden MS-120BK Electric Stimulator TL-260T BR-933PA GZ-120P BR-943PA GZ-130P QP-160AK EEG TREND PROGRAM PE-210A Nihon Kohden PE-210AK Switch Box for EEG-1200A NEUROFAX, MODELS EEG-1100A with EEG-9100A AND JUNCTION BOX FUNCTIONS LS-901AJ YZ-0226 QP-150AK EEG-9100A KE-910A EEG-9200A MULTIPLE PATIENT RECEIVER ORG-9700A Nihon Kohden QP-160AK EEG Trend Program QP-101BK MEE-1000A NEUROMASTER YP-845T YP-810P YP-817P YS-112P4 YP-811P YN-980S YP-841T YP-844T YP-842T YP-840T YP-812P YP-813P YP-815P YP-816P GZ-140P YP-843T YN-981S YP-814P LIFE SCOPE® G9 YS-106P9 BSM-1753 AY-673P A/EJ110-0010 Cable YL-920P YS-108P1 BSM-1773 YS-106P6 YS-105P6 JA-690PA DM-190P AY-653P YS-106P5 YS-105P0 DM-191P YS-105P5 YS-108P0 YN-924P YS-107P1 AY-651P JA-920P YS-106P8 YS-094P2 YS-107P9 YS-105P8 CU-192R A/326391 Cable WS-960P YS-105P7 YS-107P2 AY-631P Nihon Kohden CSM-1901 Bedside Monitor AY-671P YS-104P5 AY-633P IF-952P A/646225 Cable A/CE620NK G9-KVM/ZA YS-106P4 YS-19003 YS-107P4 SB-920P BSM-1733 YS-107P3 YS-108P2 YS-106P3 YS-106P7 YN-925P JS-210B JS-201B JB-210B BM-121B MEE-2000A-DT DC-200B Neural Function Measuring System MEE-2000 YB-201B Neuromaster G1 MEE-2000 JS-202B JB-316B JB-232B JS-204B VD-403B MEE-2000A-LT JS-203B SKIN PURE Nihon Kohden TG-970P Sensor Kit w/ Airway Adapter YG-213T

    Establishment Types

    Manufacture Medical Device