BEUDAMED
    FDA Registration Active 🇫🇷 France

    GXO Logistics H France

    Reg #: 3043014136 · FEI: 3043014136 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    GXO Logistics H France
    Registration Number
    3043014136
    FEI Number
    3043014136
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    500 Rue Colonel Louis Lemaire
    City
    Andrezieux-Boutheon Loire
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K233159

    Owner / Operator

    Firm Name
    FRESENIUS MEDICAL CARE
    Operator Number
    8010838
    Address
    ELSE KROENER-STRASSE 1, --
    City
    BAD HOMBURG
    State
    Hesse
    Postal Code
    D-61352
    Country
    DE

    US Agent

    Business Name
    VP Regulatory Affairs NA
    Contact Name
    Denise Oppermann
    Address
    920 Winter St
    City
    North Waltham
    State
    MA
    ZIP
    02451
    Country
    US
    Email
    [email protected]
    Phone
    781 9969103

    Products

    Device Name Product Code
    Dialysate Concentrate For Hemodialysis (Liquid Or Powder) KPO
    Disinfectant, Dialysate Delivery System NII
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
    Set, Tubing, Blood, With And Without Anti-Regurgitation Valve FJK
    Subsystem, Water Purification FIP
    Accessories, Blood Circuit, Hemodialysis KOC

    Proprietary Names

    pureFLOW 400, pureFLOW 401, pureFLOW 402, pureFLOW 406 DIASAFEplusUS Bicarby Dialysate FX CorAL Dialyzers 5008X Hemodialysis System FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device