BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    SYSMEX CORPORATION ONO FACTORY

    Reg #: 3010188738 · FEI: 3002808299 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    56
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    SYSMEX CORPORATION ONO FACTORY
    Registration Number
    3010188738
    FEI Number
    3002808299
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    17 Takumidai
    City
    Ono Hyogo
    Country
    JP

    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
    Diluent, Blood Cell GIF
    Stain, Reticulocyte GJH
    Container, Specimen, Non-Sterile NNI
    Stains, Hematology KQC
    General Purpose Reagent PPM
    Products, Red-Cell Lysing Products GGK

    Proprietary Names

    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 UFII SEARCH-SED UFII SEARCH-BAC UF-Fluorocell CR UF-Fluorocell SF SB Cuvette Reaction Tube Cuvette STROMATOLYSER NR (S) FLUOROCELL WPC FLUOROCELL WNR FLUOROCELL WDF FLUOROCELL PLT FLUOROCELL RET 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 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

    Establishment Types

    Manufacture Medical Device