BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    ELCAM MEDICAL ACAL

    Reg #: 3006891665 · FEI: 3006891665 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    19
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    ELCAM MEDICAL ACAL
    Registration Number
    3006891665
    FEI Number
    3006891665
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    D.N. MEROM HAGALIL
    City
    DALTON INDUSTRIAL PARK, P.O BOX 9 Northern
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K190489

    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, SUITE 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
    Transducer, Blood-Pressure, Extravascular DRS
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
    Catheter, Intravascular, Diagnostic DQO
    Syringe, Piston FMF
    Set, Administration, Intravascular FPA

    Proprietary Names

    D600 Discofix ® High– Flow Stopcock Elcam Stopcocks and Manifolds with improved blister Elcam Stopcocks and Manifolds DISPOSABLE TRANSPAC(R) ML INTEGRATE SafePort I&S Manifold (or Stopcock), Stopcocks and Manifolds Y-Click Connector Marvelous™ Closed Stopcock and MRVLS Ultraport™ High Flow Stopcock ULTRAPORT™ zer0 High Flow Stopcock H-Flow Valve Elcam Stopcocks and Manifolds with Safe2 Rotator A-TAP Transducer STRAIGHT TRANSDUCER(IT) Elcam HP HP Stopcock, MP Stopcock, HP Manifold, PHP Manifold SafePort(TM) Manifold (or Stopcock)

    Establishment Types

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