BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Respironics Deutschland GmbH & Co.KG

    Reg #: 3001400310 · FEI: 3001400310 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    51
    Establishment Types
    1
    Classifications
    7

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    Registration Details

    Registration Name
    Respironics Deutschland GmbH & Co.KG
    Registration Number
    3001400310
    FEI Number
    3001400310
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Gewerbestr. 17
    City
    Herrsching Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K091271

    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
    1001 Murry Ridge Ln
    City
    Murrysville
    State
    PA
    ZIP
    15668
    Country
    US
    Email
    [email protected]
    Phone
    978 9415572

    Products

    Device Name Product Code
    Ventilator, Non-Continuous (Respirator) BZD
    Ventilator, Continuous, Non-Life-Supporting MNS
    Ventilator, Continuous, Facility Use CBK
    Continuous, Ventilator, Home Use NOU
    Generator, Oxygen, Portable CAW
    Sv70 Ventilator MNT
    Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer BZE

    Proprietary Names

    Performax, FitLife EE Total Face Mask PC Direct Omnilab Direct Omnilab Advanced/Advanced + BiPAP autoSV Advanced System One BiPAP w/ & w/o Humidifier DreamStation BiPAP autoSV w/ & w/o Humidifier DreamStation BiPAP S/T w/ & w/o Humidifier DreamStation BiPAP AVAPS w/ & w/o Humidifier Trilogy Nurse Call Adaptor Cable Trilogy Evo Ventilator Nurse Call Rj9 Adapter Cable Open Dual Limb Active Exhalation Valve Nurse Call Adaptor Cable – Alarm Open/Closed Trilogy EV300 12/24V Battery Cable w/terminals or adapter External Flow Sensor Assembly Adult/Pediatric OR Pediatric/Infant EverFlo EverFlo Quiet OPI and non-OPI Ultrafill Quiet Everflo Ultrafill Transfill Everflo/Everflo Q/L4 DreamWear Full Mask DreamWear Nasal Mask DreamWisp Nasal Mask DreamStation BiPAP Auto w/ & w/o Humidifier Dreamstation CPAP Auto w/ & w/o Humidifier REMstar Auto A-flex HT (Q-series) DreamStation CPAP 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 DirectView Data Management System Encore Anywhere A40 Heated Humidifier OMNILAB DIRECT Universal Battery Pack (UBP2) BiPAP A40 Ventilatory Support System Dreamstation 2 Advanced System Dreamstation 2 System SimplyGo POC SimplyFlo POC SimplyGo Mini POC Respironics Disposable Heated Wire Circuits Disposable Adult/Ped Heated Active Circuit Disposable Adult/Ped Heated Passive Circuit

    Establishment Types

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