BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Optimus, Velara

    Reg #: 3003768251 · FEI: 3003768251 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Philips Medical Systems DMC GmbH
    Registration Number
    3003768251
    FEI Number
    3003768251
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Roentgenstrasse 24
    City
    HAMBURG
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K933650

    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
    Generator, High-Voltage, X-Ray, Diagnostic IZO

    Proprietary Names

    Optimus, Velara

    Establishment Types

    Manufacture Medical Device