BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FENWAL INTERNATIONAL, INC.

    Reg #: 2648979 · FEI: 1000222291 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    13
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    FENWAL INTERNATIONAL, INC.
    Registration Number
    2648979
    FEI Number
    1000222291
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    CAMINO REAL INDUSTRIAL PARK,, ROAD No. 122
    City
    San German
    State
    PR
    ZIP
    00683
    Country
    US

    Regulatory Submissions

    510(k) Number
    BK230825

    Owner / Operator

    Firm Name
    Fresenius Kabi AG
    Operator Number
    9027285
    Address
    Else-Kroner-Str. 1
    City
    61352 Bad Homburg
    State
    DE-NOTA
    Postal Code
    NONE
    Country
    DE

    Products

    Device Name Product Code
    Separator, Automated, Blood Cell, Diagnostic GKT

    Proprietary Names

    ALYX 2RBC-LR Kit Alyx Component Collection System AMICUS SEPARATOR SYSTEM ALYX Component Collection System ALYX 2 RBC-LR Kit Alyx Red Cell Kit LOVO Med Cell Processing System ALYX 2RBC LR Kit with Saline Spike ALYX 2RBC DISPOSABLE SET ALYX COMPONENT COLLECTION SYSTEM (ALYX BY FENWAL) ALYX COMPONENT COLLECTION SYSTEM (ALYX CLASSIC) ALYX PLASMA KIT ALYX COMPONENT COLLECTION SYSTEM

    Establishment Types

    Manufacture Medical Device Manufacture Device in the United States for Export Only