BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    SB-170P

    Reg #: 3013501110 · FEI: 3013501110 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    44
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center
    Registration Number
    3013501110
    FEI Number
    3013501110
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1-1-6 Kusunokidai, Tokorozawa-Shi, Saitama
    City
    Tokorozawa Saitama
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K171765

    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
    Endoscopic Bite Block MNK

    Proprietary Names

    SB-170P YG-232T YG-214T DH-380P YG-122T JL-030U2 YG-213T TG-980P YG-282T TL-201T DH-171P TG-970P JL-030U1 TG-900P TL-062S TL-220T TL-051S TL-631T1 TG-920P YG-242T JL-500P1 TL-272T TL-535U TL-631T3 YS-100P7 YG-101T TL-273T TL-274T TL-273T3 YG-211T HIT-100 TL-052S DH-172P JG-900P TL-272T3 TL-061S TL-271T TL-271T3 TG-101T YG-227T KC-170P TL-274T3 YG-272T YG-111T

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility