BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    REMSTAR PLUS CPAP 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
    K010263

    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
    Ventilator, Non-Continuous (Respirator) BZD
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT

    Proprietary Names

    REMSTAR PLUS CPAP SYSTEM

    Establishment Types

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