BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    MEDINOL LTD.

    Reg #: 9710284 · FEI: 3003084171 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    MEDINOL LTD.
    Registration Number
    9710284
    FEI Number
    3003084171
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    KIRYAT ATIDIM, BLDG. 8
    City
    TEL-AVIV Tel Aviv
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K162434
    PMA Number
    P170008

    Owner / Operator

    Firm Name
    MEDINOL LTD.
    Operator Number
    9031416
    Address
    Kiryat Atidim, Bldg. 8
    City
    Tel Aviv
    State
    IL-TA
    Postal Code
    6158101
    Country
    IL

    US Agent

    Business Name
    CardioMed Device Consultants, LLC
    Contact Name
    H. Semih Oktay
    Address
    1783 Forest Drive #254
    City
    Annapolis
    State
    MD
    ZIP
    21401
    Country
    US
    Email
    [email protected]
    Phone
    410 6742060

    Products

    Device Name Product Code
    Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX
    Coronary Drug-Eluting Stent NIQ
    Stents, Drains And Dilators For The Biliary Ducts FGE

    Proprietary Names

    NC Gallant PTCA Dilatation Catheter Gallant PTCA Dilatation Catheter EluNIR™ Ridaforolimus Eluting Coronary Stent System X-Suit NIR® Biliary Metallic Stent

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility