BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    Philips Medical Systems Nederland B.V.

    Reg #: 3000976525 · FEI: 3000976525 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    20
    Establishment Types
    3
    Classifications
    8

    Registration Details

    Registration Name
    Philips Medical Systems Nederland B.V.
    Registration Number
    3000976525
    FEI Number
    3000976525
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    High Tech Campus 36
    City
    Eindhoven Noord-Brabant
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K213544

    Owner / Operator

    Firm Name
    Philips Medical Systems International BV
    Operator Number
    1217116
    Address
    Veenpluis 6
    City
    Best
    State
    NL-NOTA
    Postal Code
    5684PC
    Country
    NL

    US Agent

    Business Name
    Philips
    Contact Name
    Martin Pedroza
    Address
    9965 Federal Drive
    City
    Colorado Springs
    State
    CO
    ZIP
    80921
    Country
    US
    Email
    [email protected]
    Phone
    440 2197243

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ
    Automated Radiological Image Processing Software QIH
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Computer, Diagnostic, Programmable DQK
    System, Tomography, Computed, Emission KPS
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, X-Ray, Angiographic IZI
    System, Network And Communication, Physiological Monitors MSX

    Proprietary Names

    TOMTEC-ARENA Xper Information Management System Xper Flex Cardio Physiomonitoring System IntelliSpace Cardiovascular Xcelera CSMC Cardiac Suite AutoQuant Philips Hemodynamic Application R1 Ultrasound Workspace QLAB Advanced Quantification Software CAAS workstation eCareManager 4.6 eCareManager 4.3 eCareManager 4.4 eCareManager 4.5 eCareManager 4.7 eCareManager 5 eCareManager 5.1 eCareManager 5.2 eCareManager 5.3

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device