BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    DreamStation 2 System, DreamStation 2 Advanced System

    Reg #: 3011120183 · FEI: 3011120183 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Plexus Electronica S. de R.L. de C.V..
    Registration Number
    3011120183
    FEI Number
    3011120183
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Paseo del Norte #4640, Guadalajara Technology Park
    City
    Zapopan Jalisco
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K200480

    Owner / Operator

    Firm Name
    PLEXUS CORP.
    Operator Number
    3019588
    Address
    ONE PLEXUS WAY, --
    City
    Neenah
    State
    WI
    Postal Code
    54956
    Country
    US

    Products

    Device Name Product Code
    Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer BZE
    Ventilator, Non-Continuous (Respirator) BZD

    Proprietary Names

    DreamStation 2 System, DreamStation 2 Advanced System

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device