BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH

    Reg #: 9611824 · FEI: 3002806960 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
    Registration Number
    9611824
    FEI Number
    3002806960
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    HAFENSTRASSE 9
    City
    SCHWEINFURT Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K243505

    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
    Subsystem, Water Purification FIP
    Accessories, Blood Circuit, Hemodialysis KOC
    Disinfectant, Dialysate Delivery System NII
    Set, Tubing, Blood, With And Without Anti-Regurgitation Valve FJK
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI

    Proprietary Names

    5008X Hemodialysis System

    Establishment Types

    Manufacture Medical Device