BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    EluNIR™ Ridaforolimus Eluting Coronary Stent System

    Reg #: 3003084171 · FEI: 3003182398 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    MEDINOL LTD.
    Registration Number
    3003084171
    FEI Number
    3003182398
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8 Hartom Street Beck Tech Bldg. Har Hotzvim B,
    City
    Jerusalem
    Country
    IL

    Regulatory Submissions

    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
    Coronary Drug-Eluting Stent NIQ

    Proprietary Names

    EluNIR™ Ridaforolimus Eluting Coronary Stent System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device