BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Sysmex America, Inc. - Vernon Hills

    Reg #: 3020704087 · FEI: 3020704087 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    73
    Establishment Types
    2
    Classifications
    12

    Registration Details

    Registration Name
    Sysmex America, Inc. - Vernon Hills
    Registration Number
    3020704087
    FEI Number
    3020704087
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1011 Woodlands Parkway
    City
    Vernon Hills
    State
    IL
    ZIP
    60061
    Country
    US

    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

    Products

    Device Name Product Code
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Automated Urinalysis System KQO
    System, Multipurpose For In Vitro Coagulation Studies JPA
    Counter, Differential Cell GKZ
    Device, Automated Cell-Locating JOY
    Slide Stainer, Automated KPA
    Counter, Urine Particle LKM
    Device, Automated Sedimentation Rate GKB
    Instrument, Coagulation, Automated GKP
    Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis PER
    Counter, Cell, Automated (Particle Counter) GKL
    Mixer, Blood Tube GLE

    Proprietary Names

    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 XE-2100DC UD-10 Sysmex XR-Series (XR-10) Automated Hematology Analyzer SP-50 SP-1000i SP-10 XN-350 XN-550 XN-430 XN-530 XN-450 XN-330 AUTOMATED HEMATOLOGY ANALYZER XW-100 UF-5000 CA-620 CA-660 XW-100 Sysmex XR-Series (XR-20) Automated Hematology Analyzer pocH-100i XS-1000iC Sysmex XN-10 Automated Hematology Analyzer CS-5100 XQ-Series (XQ-520) Automated Hematology Analyzer XQ-Series (XQ-320) Automated Hematology Analyzer XE-2100D XN-20 XN-10 XN-11 XP-300

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)