BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    SYSMEX CORPORATION i-SQUARE

    Reg #: 3010960914 · FEI: 3010960914 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    62
    Establishment Types
    1
    Classifications
    9

    Registration Details

    Registration Name
    SYSMEX CORPORATION i-SQUARE
    Registration Number
    3010960914
    FEI Number
    3010960914
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    262-11 Mizuashi, Noguchicho
    City
    Kakogawa Hyogo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K151259

    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
    System, Multipurpose For In Vitro Coagulation Studies JPA
    Instrument, Coagulation, Automated GKP
    Slide Stainer, Automated KPA
    Mixer, Blood Tube GLE
    Counter, Differential Cell GKZ
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Device, Automated Cell-Locating JOY
    Counter, Urine Particle LKM
    Medical Device Data System OUG

    Proprietary Names

    CS-2500 CA-7000 SP-50 SP-1000i SP-10 Pneumatic Unit (PU-17) XN-11 Automated Blood Coagulation Analyzer CN-6000 Automated Blood Coagulation Analyzer CN-3000 CS-5100 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 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 XR-Series (XR-10) Automated Hematology Analyzer Sysmex XR-Series (XR-20) Automated Hematology Analyzer UD-10 Sysmex XN-10 Automated Hematology Analyzer XN-20 XN-10 UF-5000 Urinalysis Data Manager (UDM) Sysmex WAM (Work Area Management) XT-4000i

    Establishment Types

    Manufacture Medical Device