BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    SYSMEX CORPORATION TECHNO PARK

    Reg #: 9613959 · FEI: 3002808301 · Expires 2026
    View on FDA
    Products
    30
    Proprietary Names
    165
    Establishment Types
    1
    Classifications
    30

    Registration Details

    Registration Name
    SYSMEX CORPORATION TECHNO PARK
    Registration Number
    9613959
    FEI Number
    3002808301
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4-4-4 TAKATSUKADAI NISHI-KU
    City
    KOBE Hyogo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K251371

    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, Urine Particle LKM
    Mixture, Hematology Quality Control JPK
    Products, Red-Cell Lysing Products GGK
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    System, Multipurpose For In Vitro Coagulation Studies JPA
    Slide Stainer, Automated KPA
    Stains, Hematology KQC
    Container, Specimen, Non-Sterile NNI
    Calibrator, Surrogate JIW
    Calibrator For Cell Indices KRX
    Urinalysis Controls (Assayed And Unassayed) JJW
    Mixer, Blood Tube GLE
    Diluent, Blood Cell GIF
    Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis PER
    General Purpose Reagent PPM
    Medical Device Data System OUG
    Counter, Cell, Automated (Particle Counter) GKL
    Control, Platelet GJP
    Device, Automated Cell-Locating JOY
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Mixture, Control, White-Cell And Red-Cell Indices GLQ
    Instrument, Coagulation, Automated GKP
    Stain, Reticulocyte GJH
    Radioimmunoassay, Thyroid-Stimulating Hormone JLW
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Calibrator, Secondary JIT
    Calibrator For Red-Cell And White-Cell Counting KSA
    Timer, General Laboratory JBS

    Proprietary Names

    Sysmex XR-Series (XR-20) Automated Hematology Analyzer UF-1000i XN-L CHECK Lysercell WPC Lysercell WNR Lysercell WDF Sulfolyser Stromatolyser-4DS XW pack L Stromatolyser-IM Stromatolyser-4DL Stromatolyser-3WP Stromatolyser-WH Stromatolyser-NR Stromatolyser-FB pocH-pack L Stromatolyser-NR(L) Lysercell WDF II 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 CS-2500 SP-50 SP-1000i SP-10 XS-1000iC STROMATOLYSER NR (S) FLUOROCELL WPC FLUOROCELL WNR FLUOROCELL WDF FLUOROCELL PLT FLUOROCELL RET XE-2100D XN-20 XN-10 SB Cuvette Reaction Tube Cuvette UF-CALIBRATOR X-CAL Calibrator e-CHECK(XE) XN-11 AUTOMATED HEMATOLOGY ANALYZER XW-100 Sysmex XN-10 Automated Hematology Analyzer UF-CONTROL UF II CALIBRATOR CELLPACK DFL Cellpack Cellsheath CELLSHEATH CCS UF-CELLSHEATH XW pack D UF-CELLPACK CR UF-CELLPACK SF Cellsheath C CELLPACK DCL UF II PACK SED UF II Sheath pocH-pack D CELLPACK S RETSEARCH II UF II PACK-BAC CELLPACK DST Sysmex XN-L Automated Hematology Analyzer XN-550 XN-330 XN-450 XN-350 XN-430 XN-530 CA CLEAN I CELLCLEAN CELLCLEAN AUTO Concentrated phosphate buffer for SP pH 6.6 Concentrated phosphate buffer for SP pH 7.2 Concentrated phosphate buffer for SP pH 6.8 Concentrated phosphate buffer for SP pH 7 XW CELLCLEAN CyFlow CLEAN CA CLEAN II CN-COAGWASHER UC-Control XN CHECK BF UF-5000 Urinalysis Data Manager (UDM) Sysmex WAM (Work Area Management) pocH-100i Platelet CHECK UD-10 EIGHTCHECK-3WP IQAS EIGHTCHECK-3WP XP-300 XE-2100DC XN CHECK XN CAL PF XS-Series (XS-800i, XS-1000i) CS-5100 XN CAL e-CHECK(XS) e-CHECK XW-100 CA-620 CA-660 UFII SEARCH-SED UFII SEARCH-BAC UF-Fluorocell CR UF-Fluorocell SF HISCL Immuno Multi Control HISCL TSH Calibrator Automated Immunoassay System HISCL-800 HISCL TSH Assay Kit CA-7000 Sysmex XR-Series (XR-10) Automated Hematology Analyzer XT-4000i SCS-1000 Calibrator WRP CHECK WRP CHECK EX XW QC CHECK XQ-Series (XQ-520) Automated Hematology Analyzer XQ-Series (XQ-320) Automated Hematology Analyzer CA CAL S AUW TRACK Automated Blood Coagulation Analyzer CN-6000 Automated Blood Coagulation Analyzer CN-3000 HISCL-5000

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility