BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    "QUADROX-iR Adult / Small Adult, with and without integrated Arterial Filter, with BIOLINE or SOFTLINE Coating;

    Reg #: 3002807090 · FEI: 3006003617 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    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
    K102726

    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
    Console, Heart-Lung Machine, Cardiopulmonary Bypass DTQ

    Proprietary Names

    "QUADROX-iR Adult / Small Adult, with and without integrated Arterial Filter, with BIOLINE or SOFTLINE Coating; HIT-Set Advanced 7 and 5 QUADROX-iR Adult / Small Adult, with and without integrated Arterial Filter, with BIOLINE or SOFTLINE Coating HLS-Set Advanced 7 and 5

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)