BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Marvelous™

    Reg #: 9612152 · FEI: 3002806901 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ELCAM MEDICAL A.C.A.L.
    Registration Number
    9612152
    FEI Number
    3002806901
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    KIBBUTZ BAR-AM
    City
    D.N. MEROM HAGALIL Northern
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K060231

    Owner / Operator

    Firm Name
    Elcam Medical ACAL
    Operator Number
    8030082
    Address
    Kibbutz BarAm
    City
    D.N Merom Hagalil
    State
    Northern
    Postal Code
    1386000
    Country
    IL
    Correspondent
    Yaniv - Menachem

    US Agent

    Business Name
    ELCAM MEDICAL INC.
    Contact Name
    Tomer Gil
    Address
    1 University Plz, Ste 511
    City
    Hackensack
    State
    NJ
    ZIP
    07601
    Country
    US
    Email
    [email protected]
    Phone
    201 4571120 ext. 112

    Products

    Device Name Product Code
    Stopcock, I.V. Set FMG

    Proprietary Names

    Marvelous™ Closed Stopcock and MRVLS Ultraport™ High Flow Stopcock ULTRAPORT™ zer0 High Flow Stopcock

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device