BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    ORGANOX LIMITED

    Reg #: 3011560054 · FEI: 3011560054 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    ORGANOX LIMITED
    Registration Number
    3011560054
    FEI Number
    3011560054
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3500 John Smith Drive, Oxford Business Park
    City
    Oxford Oxfordshire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K133658
    PMA Number
    P200035

    Owner / Operator

    Firm Name
    OrganOx Limited
    Operator Number
    10084836
    Address
    3500 John Smith Drive, Oxford Business Park South
    City
    Oxford
    State
    Oxfordshire
    Postal Code
    OX4 2WB
    Country
    GB

    Products

    Device Name Product Code
    Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass DRY
    Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation QQK

    Proprietary Names

    OrganOx metra Liver Perfusion Circuit Pack OrganOx metra

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device