BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Sysmex America, Inc.

    Reg #: 3009495621 · FEI: 3009495621 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sysmex America, Inc.
    Registration Number
    3009495621
    FEI Number
    3009495621
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    SAI - Multi-Purpose Building, 1701 Leider Lane
    City
    Buffalo Grove
    State
    IL
    ZIP
    60089
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160538

    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
    Counter, Differential Cell GKZ

    Proprietary Names

    XN-350 XN-550 XN-430 XN-530 XN-450 XN-330

    Establishment Types

    Manufacture Medical Device