BEUDAMED
    FDA Registration Active 🇮🇳 India

    Philips India Limited - Diagnostic X-ray Business Unit

    Reg #: 3033527770 · FEI: 3033527770 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    19
    Establishment Types
    1
    Classifications
    8

    Registration Details

    Registration Name
    Philips India Limited - Diagnostic X-ray Business Unit
    Registration Number
    3033527770
    FEI Number
    3033527770
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Philips Innovation Campus, Embassy Business Hub, Venkatala Village, Yelahanka Hobli, Yelahanka
    City
    Bengaluru Karnataka
    Country
    IN

    Regulatory Submissions

    510(k) Number
    K212837

    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 MEDICAL SYSTEMS INTERNATIONAL BV
    Contact Name
    Maria Heiling
    Address
    3721 Valley Centre Dr., Ste. 500
    City
    San Diego
    State
    CA
    ZIP
    92130
    Country
    US
    Email
    [email protected]
    Phone
    858 2487651

    Products

    Device Name Product Code
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, X-Ray, Stationary KPR
    System, Image Processing, Radiological LLZ
    Interventional Fluoroscopic X-Ray System OWB
    Table, Radiographic, Tilting IXR
    Device, Spot-Film IXL
    System, X-Ray, Mobile IZL

    Proprietary Names

    ProxiDiagnost N90 Precision CRF DigitalDiagnost C90 CombiDiagnost R90 DigitalDiagnost ProGrade SkyPlate DuoDiagnost Radiography 7300 C Film and Accessories EasyDiagnost Eleva Radiography 7000 M SkyFlow ProxiDiagnost N90 / Precision CRF PCR Eleva S Plus PCR Eleva Corado PCR Eleva S HI Res PCR Eleva S PCR Cosima X Eleva

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility