BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    OSMS

    Reg #: 3014404697 · FEI: 3014404697 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Demant Technology Centre Sp. z o.o.
    Registration Number
    3014404697
    FEI Number
    3014404697
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Q22, Al. Jana Pawla II 22, 9th Floor
    City
    Warsaw Mazowieckie
    Country
    PL

    Regulatory Submissions

    510(k) Number
    K123371

    Owner / Operator

    Firm Name
    VISION RT LIMITED
    Operator Number
    9063759
    Address
    Dove House, Arcadia Avenue
    City
    LONDON
    State
    London, City of
    Postal Code
    N3 2JU
    Country
    GB
    Correspondent
    Amy Mansfield

    Products

    Device Name Product Code
    Accelerator, Linear, Medical IYE

    Proprietary Names

    OSMS AlignRT AlignRT Plus GateCT system GateRT system AlignRT system AlignRT SRS module

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility