BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Xenios AG

    Reg #: 3012172416 · FEI: 3012172416 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    16
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Xenios AG
    Registration Number
    3012172416
    FEI Number
    3012172416
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Im Zukunftspark 1
    City
    Heilbronn Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K232926

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

    Proprietary Names

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

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility