BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    QUADROX-i Pediatric Micorporous Membrane Oxygenator with and without integrated Arterial Filter with SOFTLINE Coating or

    Reg #: 3005941719 · FEI: 3002807111 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Sterigenics Belgium Petit Rechain S.A.
    Registration Number
    3005941719
    FEI Number
    3002807111
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Zoning Industriel de Petit-Rechain, Avenue Andre Ernst 21
    City
    Verviers Liege
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K103191

    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
    Oxygenator, Cardiopulmonary Bypass DTZ
    Heat-Exchanger, Cardiopulmonary Bypass DTR
    Filter, Blood, Cardiopulmonary Bypass, Arterial Line DTM

    Proprietary Names

    QUADROX-i Pediatric Micorporous Membrane Oxygenator with and without integrated Arterial Filter with SOFTLINE Coating or

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)