BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MC3 Nautilus ECMO Oxygenator with Balance Biosuface

    Reg #: 3011468686 · FEI: 3011468686 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MC3, Inc.
    Registration Number
    3011468686
    FEI Number
    3011468686
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2555 Bishop Circle West
    City
    Dexter
    State
    MI
    ZIP
    48130
    Country
    US

    Owner / Operator

    Firm Name
    Medtronic, Inc.
    Operator Number
    2112641
    Address
    710 Medtronic Parkway
    City
    Minneapolis
    State
    MN
    Postal Code
    55432
    Country
    US

    Products

    Device Name Product Code
    Oxygenator, Long Term Support Greater Than 6 Hours BYS

    Proprietary Names

    MC3 Nautilus ECMO Oxygenator with Balance Biosuface MC3 Nautilus Smart ECMO Module with Balance Biosuface

    Establishment Types

    Manufacture Device in the United States for Export Only