BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    SYSMEX CORPORATION

    Reg #: 3010421384 · FEI: 3010421384 · Expires 2026
    View on FDA
    Products
    21
    Proprietary Names
    144
    Establishment Types
    2
    Classifications
    21

    Registration Details

    Registration Name
    SYSMEX CORPORATION
    Registration Number
    3010421384
    FEI Number
    3010421384
    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
    Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis PER
    Counter, Differential Cell GKZ
    Diluent, Blood Cell GIF
    Counter, Urine Particle LKM
    Products, Red-Cell Lysing Products GGK
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    System, Multipurpose For In Vitro Coagulation Studies JPA
    Counter, Cell, Automated (Particle Counter) GKL
    Container, Specimen, Non-Sterile NNI
    Slide Stainer, Automated KPA
    Stain, Reticulocyte GJH
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Instrument, Coagulation, Automated GKP
    Urinalysis Controls (Assayed And Unassayed) JJW
    Radioimmunoassay, Thyroid-Stimulating Hormone JLW
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Calibrator, Secondary JIT
    Device, Automated Cell-Locating JOY
    Calibrator, Surrogate JIW
    Stains, Hematology KQC
    General Purpose Reagent PPM

    Proprietary Names

    Sysmex XR-Series (XR-20) Automated Hematology Analyzer XT-4000i 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 UF-5000 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 HISCL-5000 CS-2500 XP-300 pocH-100i Sysmex XN-10 Automated Hematology Analyzer CS-5100 XN-350 XN-550 XN-430 XN-530 XN-450 XN-330 SB Cuvette Reaction Tube Cuvette XE-2100D SP-50 SP-1000i SP-10 UFII SEARCH-SED UFII SEARCH-BAC UF-Fluorocell CR UF-Fluorocell SF 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 Automated Blood Coagulation Analyzer CN-6000 Automated Blood Coagulation Analyzer CN-3000 CA-7000 UF-CONTROL UF II CALIBRATOR XS-Series (XS-800i, XS-1000i) HISCL Immuno Multi Control HISCL TSH Calibrator Automated Immunoassay System HISCL-800 HISCL TSH Assay Kit UF-1000i CA CAL S CA-620 CA-660 UD-10 XN-11 XN-20 XN-10 AUTOMATED HEMATOLOGY ANALYZER XW-100 XE-2100DC UF-CALIBRATOR XQ-Series (XQ-520) Automated Hematology Analyzer XQ-Series (XQ-320) Automated Hematology Analyzer XW-100 STROMATOLYSER NR (S) FLUOROCELL WPC FLUOROCELL WNR FLUOROCELL WDF FLUOROCELL PLT FLUOROCELL RET XS-1000iC 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 Sysmex XR-Series (XR-10) Automated Hematology Analyzer

    Establishment Types

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