BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    SYSMEX CORPORATION SEISHIN FACTORY

    Reg #: 3007701696 · FEI: 3007701696 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    SYSMEX CORPORATION SEISHIN FACTORY
    Registration Number
    3007701696
    FEI Number
    3007701696
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4-3-2 Takatsukadai, Nishi-ku
    City
    Kobe Hyogo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K011235

    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
    Calibrator, Surrogate JIW
    System, Multipurpose For In Vitro Coagulation Studies JPA
    Counter, Urine Particle LKM
    Urinalysis Controls (Assayed And Unassayed) JJW

    Proprietary Names

    UF-CALIBRATOR CA CAL S UF-1000i UF-CONTROL UF II CALIBRATOR

    Establishment Types

    Manufacture Medical Device