BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    N-GENEOUS LDL CHOLESTEROL

    Reg #: 3003539867 · FEI: 3006769061 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    SEKISUI MEDICAL CO., LTD. Tsukuba Plant
    Registration Number
    3003539867
    FEI Number
    3006769061
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3-1, KOYODAI 3-CHOME
    City
    Ryugasaki-shi Ibaraki
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K971573

    Owner / Operator

    Firm Name
    SEKISUI MEDICAL CO., LTD.
    Operator Number
    9030526
    Address
    1-3, Nihonbashi 2-chome, Chuo-ku
    City
    Tokyo
    State
    JP-13
    Postal Code
    103-0027
    Country
    JP

    US Agent

    Business Name
    Sekisui Diagnostics, LLC
    Contact Name
    Jason Bilobram
    Address
    One Wall Street
    City
    Burlington
    State
    MA
    ZIP
    01803
    Country
    US
    Email
    [email protected]
    Phone
    781 6527848

    Products

    Device Name Product Code
    Calibrator, Multi-Analyte Mixture JIX
    Calibrator, Primary JIS
    Ldl & Vldl Precipitation, Hdl LBR

    Proprietary Names

    N-GENEOUS LDL CHOLESTEROL

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)