BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    TG-921T3

    Reg #: 3016852448 · FEI: 3016852448 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    2

    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
    K050833

    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
    Full-Montage Standard Electroencephalograph GWQ
    Standard Polysomnograph With Electroencephalograph OLV

    Proprietary Names

    TG-921T3 TL-052S JE-921A TL-062S TL-201T TL-220T

    Establishment Types

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