BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

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

    Reg #: 3005941719 · FEI: 3002807111 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    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
    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)