BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Nagase Diagnostics Co., Ltd.

    Reg #: 3003460426 · FEI: 3003460426 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    3

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    Registration Details

    Registration Name
    Nagase Diagnostics Co., Ltd.
    Registration Number
    3003460426
    FEI Number
    3003460426
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    12-15, Nihonbashi-Kobunacho,
    City
    Chuo-ku Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K170147

    Owner / Operator

    Firm Name
    Nagase Diagnostics Co., Ltd.
    Operator Number
    10059378
    Address
    12-15, Nihonbashi-Kobunacho
    City
    Chuo-ku
    State
    Tokyo
    Postal Code
    103-0024
    Country
    JP

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Assay, Glycosylated Hemoglobin LCP
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Calibrator, Secondary JIT

    Establishment Types

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