BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    XN-10

    Reg #: 3010421384 · FEI: 3010421384 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SYSMEX CORPORATION
    Registration Number
    3010421384
    FEI Number
    3010421384
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4-4-4 TAKATSUKADAI NISHI-KU
    City
    KOBE Hyogo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K112605

    Owner / Operator

    Firm Name
    SYSMEX CORPORATION
    Operator Number
    9014170
    Address
    4-4-4 TAKATSUKADAI, NISHI-KU
    City
    KOBE
    State
    JP-NOTA
    Postal Code
    651-2271
    Country
    JP

    US Agent

    Business Name
    SYSMEX AMERICA, INC
    Contact Name
    Simon C. Shorter
    Address
    577 APTAKISIC RD
    City
    Lincolnshire
    State
    IL
    ZIP
    60069
    Country
    US
    Email
    [email protected]
    Phone
    408 8380220

    Products

    Device Name Product Code
    Counter, Differential Cell GKZ

    Proprietary Names

    XN-10 XN-20

    Establishment Types

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