BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Urinalysis Data Manager (UDM)

    Reg #: 1422681 · FEI: 1000515253 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SYSMEX AMERICA, INC.
    Registration Number
    1422681
    FEI Number
    1000515253
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ONE 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
    Medical Device Data System OUG

    Proprietary Names

    Urinalysis Data Manager (UDM) Sysmex WAM (Work Area Management)

    Establishment Types

    Manufacture Medical Device