BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    SYSMEX CORPORATION KAKOGAWA FACTORY

    Reg #: 3002759288 · FEI: 3002759288 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    61
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    SYSMEX CORPORATION KAKOGAWA FACTORY
    Registration Number
    3002759288
    FEI Number
    3002759288
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    314-2 Kitano, Noguchi-cho
    City
    Kakogawa Hyogo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K032677

    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
    Counter, Cell, Automated (Particle Counter) GKL
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Instrument, Coagulation, Automated GKP

    Proprietary Names

    pocH-100i XS-Series (XS-800i, XS-1000i) AUTOMATED HEMATOLOGY ANALYZER XW-100 XW-100 XN-350 XN-550 XN-430 XN-530 XN-450 XN-330 XE-2100DC Option Sampler SA-90 XS-1000i sampler (OPSU-11) HST-N SA-31 Barcode Terminal (BT-40) ST-40 SA-30 AlphaN-SPSU CV-65 RB-10 Pneumatic Unit (PU-17) SA-02 RU-10 ST-42 SA-10 SA-20 SA-21 ST-41 CV-60 SA-01 CF-70 CV-50 RR-20 RR-10 COMPLETE OPSU-6 CV-55 AlphaN-XESU RU-21 TS-10 RU-20 CV-70 TU-40 CF-60 SA-51 U-RDU CV-11 TH-11 BT-50 TS-01 Automated Tube Sorter TA-01 Automated Tube Archiver Urine Sample Transportation Unit ST-10 Urine Sample Transportation Unit ST-11 Urine Sample Transportation Unit ST-12 Sysmex XN-L Automated Hematology Analyzer XP-300 XE-2100D CA-7000 XS-1000iC XQ-Series (XQ-520) Automated Hematology Analyzer XQ-Series (XQ-320) Automated Hematology Analyzer

    Establishment Types

    Manufacture Medical Device