BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    P110039

    Reg #: 9615058 · FEI: 3003105983 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    INSIGHTEC, LTD.
    Registration Number
    9615058
    FEI Number
    3003105983
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5 NAHUM HETH ST.
    City
    TIRAT CARMEL Haifa
    Country
    IL

    Regulatory Submissions

    PMA Number
    P110039

    Owner / Operator

    Firm Name
    INSIGHTEC, LTD.
    Operator Number
    9039651
    Address
    5 NAHUM HETH ST., --
    City
    TIRAT CARMEL
    State
    IL-NOTA
    Postal Code
    39120
    Country
    IL

    US Agent

    Business Name
    INSIGHTEC, INC.
    Contact Name
    NADIR ALIKACEM
    Address
    4851 Lbj Fwy Ste 300
    City
    DALLAS
    State
    TX
    ZIP
    75244
    Country
    US
    Email
    [email protected]
    Phone
    214 6302000

    Products

    Device Name Product Code
    Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided NRZ

    Proprietary Names

    P110039

    Establishment Types

    Manufacture Medical Device