BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    VIVONIC GMBH

    Reg #: 3010850471 · FEI: 3010850471 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    VIVONIC GMBH
    Registration Number
    3010850471
    FEI Number
    3010850471
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Kurfuerst-Eppstein-Ring 4
    City
    Sailauf Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K143617

    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
    Vice President 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

    Proprietary Names

    AquaC UNO H AquaBplus & AquaBplus B2 & AquaBplus HF AquaBplus AquaBplus & AquaBplus B2 AquaBplus & AquaBplus HF AquaA Aqua C UNO H AquaB LITE

    Establishment Types

    Manufacture Medical Device