BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    QUADROX-i Microporous Membrane Oxygenator w and w/o Arterial Filter with holding clamp

    Reg #: 3002807090 · FEI: 3006003617 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Sterigenics Germany GmbH
    Registration Number
    3002807090
    FEI Number
    3006003617
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Kasteler Straße 45
    City
    Wiesbaden Hesse
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K132829

    Owner / Operator

    Firm Name
    Sotera Health LLC
    Operator Number
    10029425
    Address
    2015 Spring Road, Suite 650
    City
    Oak Brook
    State
    IL
    Postal Code
    60523
    Country
    US
    Correspondent
    Karen Whaley-Krumins

    Products

    Device Name Product Code
    Heat-Exchanger, Cardiopulmonary Bypass DTR
    Filter, Blood, Cardiopulmonary Bypass, Arterial Line DTM
    Oxygenator, Cardiopulmonary Bypass DTZ

    Proprietary Names

    QUADROX-i Microporous Membrane Oxygenator w and w/o Arterial Filter with holding clamp QUADROX-iD Diffusion Membrane Oxygenator with Holding Clamp.

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)