BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    DreamStation CPAP w/ & w/o Humidifier

    Reg #: 3001400310 · FEI: 3001400310 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Respironics Deutschland GmbH & Co.KG
    Registration Number
    3001400310
    FEI Number
    3001400310
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Gewerbestr. 17
    City
    Herrsching Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K131982

    Owner / Operator

    Firm Name
    Philips Medical Systems International BV
    Operator Number
    2518422
    Address
    Veenpluis 6
    City
    Best
    State
    NL-NOTA
    Postal Code
    5684PC
    Country
    NL

    US Agent

    Business Name
    Philips
    Contact Name
    Tom Fallon
    Address
    6501 Living Place
    City
    Pittsburgh
    State
    PA
    ZIP
    15206
    Country
    US
    Email
    [email protected]
    Phone
    978 9415572

    Products

    Device Name Product Code
    Ventilator, Non-Continuous (Respirator) BZD

    Proprietary Names

    DreamStation CPAP w/ & w/o Humidifier DreamStation BiPAP Auto w/ & w/o Humidifier REMstar Auto A-flex HT (Q-series) Dreamstation CPAP Auto w/ & w/o Humidifier Dreamstation CPAP Pro w/ & w/o Humidifier DreamStation BiPAP Pro w/ & w/o Humidifier DreamStation Go CPAP DreamStation Go Auto CPAP Dreamstation GO w/ & w/o Humidifier DreamStation CPAP Assist

    Establishment Types

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