BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SYSMEX REAGENTS AMERICA, INC.

    Reg #: 3006949423 · FEI: 3006949423 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    32
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SYSMEX REAGENTS AMERICA, INC.
    Registration Number
    3006949423
    FEI Number
    3006949423
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Two Sysmex Way
    City
    Mundelein
    State
    IL
    ZIP
    60060
    Country
    US

    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
    Diluent, Blood Cell GIF
    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 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 for Another Party (Contract Manufacturer)