BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    Philips Polska Sp. z o.o.

    Reg #: 3038281851 · FEI: 3038281851 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    4

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    Registration Details

    Registration Name
    Philips Polska Sp. z o.o.
    Registration Number
    3038281851
    FEI Number
    3038281851
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Pilsudskiego 88
    City
    Lodz Lodzkie
    Country
    PL

    Regulatory Submissions

    510(k) Number
    K072286

    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
    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
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Reduced- Montage Standard Electroencephalograph OMC
    Index-Generating Electroencephalograph Software OLW
    Burst Suppression Detection Software For Electroencephalograph ORT

    Proprietary Names

    453564561901 M_BIS OEM BIS LoC 4-CH Device PWR Link 451261003621 M_BIS BISx Power Link ROHS 453564453711 M_BIS BISx Power Link

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device