BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    XENIOS AG

    Reg #: 3002845651 · FEI: 3002845651 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    16
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    XENIOS AG
    Registration Number
    3002845651
    FEI Number
    3002845651
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Obere Steinfurt 8-10
    City
    Stolberg North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K191407

    Owner / Operator

    Firm Name
    Xenios AG
    Operator Number
    10045964
    Address
    Im Zukunftspark 1
    City
    Heilbronn
    State
    Baden-Wurttemberg
    Postal Code
    74076
    Country
    DE

    US Agent

    Business Name
    Fresenius Medical Care North America
    Contact Name
    Denise M Oppermann
    Address
    920 Winter Street
    City
    Waltham
    State
    MA
    ZIP
    02451
    Country
    US
    Email
    [email protected]
    Phone
    781 6994479

    Products

    Device Name Product Code
    Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure QJZ
    Tubing, Long Term Support Greater Than 6 Hours QWF
    Oxygenator, Long Term Support Greater Than 6 Hours BYS

    Proprietary Names

    Trolley N Flow Sensor 3/8”x3/32” Support for backup pump drive Novalung console Novalung power supply Novalung control panel Novalung sensor box Infusion Stand compact Novalung System Novalung battery pack Compact holder XLung kit Novalung pump drive DP3 IPS Pressure Sensor connecting cable Novalung Console Extracorporeal system for long-term respiratory / cardiopulmonary failure

    Establishment Types

    Manufacture Medical Device