BEUDAMED
    FDA Registration Active 🇮🇳 India

    Zenition 50

    Reg #: 3033525987 · FEI: 3033525987 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Philips India Limited - Image Guided Therapy Systems Business Unit
    Registration Number
    3033525987
    FEI Number
    3033525987
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Devi ICC Gaurav Tech Park Old Mumbai-Pune Highway Pimpri, 1st Floor
    City
    Pune Maharashtra
    Country
    IN

    Regulatory Submissions

    510(k) Number
    K183101

    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
    Interventional Fluoroscopic X-Ray System OWB
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    System, X-Ray, Fluoroscopic, Image-Intensified JAA

    Proprietary Names

    Zenition 50

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility