BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    pureFLOW 400, pureFLOW 401, pureFLOW 402, pureFLOW 406

    Reg #: 3017491691 · FEI: 3017491691 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DSV Solutions NV
    Registration Number
    3017491691
    FEI Number
    3017491691
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Evenstuk 4
    City
    Gent Oost-Vlaanderen
    Country
    BE

    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

    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

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