BEUDAMED
    FDA Registration Active 🇮🇳 India

    Philips India Limited - Diagnostic X-ray Business Unit

    Reg #: 3033525986 · FEI: 3033525986 · 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
    3033525986
    FEI Number
    3033525986
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Devi ICC Gaurav Tech Park Old Mumbai-Pune Road, Pimpri-Waghere, Ground Floor,
    City
    Pimpri Maharashtra
    Country
    IN

    Regulatory Submissions

    510(k) Number
    K163210

    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
    System, X-Ray, Stationary KPR
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    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

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

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility