BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    pureFLOW 400, pureFLOW 401, pureFLOW 402, pureFLOW 406

    Reg #: 9611823 · FEI: 3002807005 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
    Registration Number
    9611823
    FEI Number
    3002807005
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    FRANKFURTER STRASSE 6-8
    City
    ST. WENDEL Saarland
    Country
    DE

    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
    Senior Director of Regulatory Affairs, Devices
    Contact Name
    Denise Oppermann
    Address
    920 Winter Street
    City
    Waltham
    State
    MA
    ZIP
    02451
    Country
    US
    Email
    [email protected]
    Phone
    781 6994479 ext. 4479

    Products

    Device Name Product Code
    Dialysate Concentrate For Hemodialysis (Liquid Or Powder) KPO

    Proprietary Names

    pureFLOW 400, pureFLOW 401, pureFLOW 402, pureFLOW 406

    Establishment Types

    Manufacture Medical Device