BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    TL-271T3

    Reg #: 8030229 · FEI: 3002807739 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    29
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NIHON KOHDEN TOMIOKA PRODUCTION CENTER
    Registration Number
    8030229
    FEI Number
    3002807739
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1-1 Tajino
    City
    TOMIOKA-SHI Gunma
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K043517

    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
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT

    Proprietary Names

    TL-271T3 A/NTX-DISP ZM-540PA TL-220T YP-944P ZM-530PA TL-271T ZM-521PA TL-062S A/NTX2-POUCH TL-274T3 YP-943P ZM-531PA BR-906PA TL-272T3 YP-503P YN-990P TL-273T3 TL-201T TL-631T3 ZM-541PA ZM-520PA TL-274T YP-504P BR-913PA BR-916PA TL-052S ZS-940PA BR-903PA

    Establishment Types

    Manufacture Medical Device