BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

    Reg #: 3042175844 · FEI: 3042175844 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    90
    Establishment Types
    2
    Classifications
    12

    Registration Details

    Registration Name
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Registration Number
    3042175844
    FEI Number
    3042175844
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    VEENPLUIS 6
    City
    BEST Noord-Brabant
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K133819

    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

    Products

    Device Name Product Code
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Interventional Fluoroscopic X-Ray System OWB
    System, Image Processing, Radiological LLZ
    Instrument, Quality-Assurance, Radiologic LHO
    Collimator, Automatic, Radiographic IZW
    System, X-Ray, Angiographic IZI
    System, X-Ray, Tomography, Computed JAK
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Table, Radiologic KXJ
    Automated Radiological Image Processing Software QIH
    Collimator, Manual, Radiographic IZX

    Proprietary Names

    Veradius Neo Azurion 7 B20 Azurion 5 M12 Azurion 3 M12 Azurion 3 M15 Azurion 7 M12 Azurion 7 M20 Azurion 5 M20 Azurion 7 B12 Dynamic Coronary Roadmap 2 722058 - Allura Xper FD20/15 722039 - Allura Xper FD20/20 OR Table 722035 - Allura Xper FD20 OR Table 722059 - Allura Xper FD20/15 OR Table 722029 - Allura Xper FD20/10 722033 - Allura Xper FD10 OR Table 722026 - Allura Xper FD10 722036 - Allura Xper FD20/10 OR Table 722027 - Allura Xper FD10/10 722034 - Allura Xper FD10/10 OR Table 722028 - Allura Xper FD20 722038 - Allura Xper FD20/20 Geometric QA Phantom - 459800438932 Philips DoseAware R1.1 DoseAware R2 DoseAware AneurysmFlow Azurion R2 Collimator IITV Square Collimator FD12 Square Collimator FD15 Collimator P225 ACS Rev 1.1 Collimator BV300 NICOL Collimator Family Square Collimator FD17 Allura Xper FD10 Allura R9 ALLURA XPER FD20 SERIES ALLURA XPER FD BIPLANE SERIES ALLURA XPER FD OR TABLE SERIES ALLURA XPER FD10 SERIES Zenition 70 SmartCT CT TrueView - 001010 Heart Navigator Release 2 Allura Xper R9 Allura Xper OR Table Series Allura 3D-CA 3D-CA CT TrueView XperCT Rel. 3 ALLURA XPER FD BIPLANE SERIES Rel 8.2 ALLURA XPER FD OR TABLE SERIES Rel 8.2 ALLURA XPER FD20 SERIES Rel 8.2 ALLURA XPER FD10 SERIES Rel 8.2 VesselNavigator Interventional Workspot Integris Allura FD R1.2 (FD10) Allura Xper FD10/10 Veradius Unity XperGuide Zenition 90 Zenition 50 Allura Xper FD series and Allura Xper OR Table series Zenition 30 EchoNavigator R3 Veradius Philips Hemodynamic Application R1 001014 - 2D Quantitative Analysis Allura Xper FD Series Radiologic Table EchoNavigator R4 BV Pulsera BV Endura EchoNavigator R5 MR-CT Roadmap Rel. 1 Allura 3D-RA Rel. 6 3D Roadmap Rel. 1 3D-RA Allura Xper FD20 Allura Xper FD20/10 Allura Xper FD20/20 FORMAT Collimator Family EP Navigator R5 Azurion series R1.2 EchoNavigator Release 1 ALLURACLARITY XPER FD SERIES X-RAY SYSTEM Stentboost R4.2 StentBoost Live EmboGuide R1

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility