BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    Optune Lua

    Reg #: 3010457505 · FEI: 3010457505 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    NOVOCURE GMBH
    Registration Number
    3010457505
    FEI Number
    3010457505
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Neuhofstrasse 21
    City
    Baar Zug
    Country
    CH

    Regulatory Submissions

    PMA Number
    P230042

    Owner / Operator

    Firm Name
    NOVOCURE INC
    Operator Number
    10044866
    Address
    1550 Liberty Ridge Dr., Suite 115
    City
    Wayne
    State
    PA
    Postal Code
    19087
    Country
    US
    Correspondent
    Lori Burns

    US Agent

    Business Name
    NOVOCURE INC.
    Contact Name
    Jennifer Henderson
    Address
    1550 Liberty Ridge Dr., Suite 115
    City
    Wayne
    State
    PA
    ZIP
    19087
    Country
    US
    Email
    [email protected]
    Phone
    603 5014290

    Products

    Device Name Product Code
    Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer SDA

    Proprietary Names

    Optune Lua

    Establishment Types

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