BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    E-Z-Link

    Reg #: 9613744 · FEI: 3002771638 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    DUOJECT MEDICAL SYSTEMS, INC.
    Registration Number
    9613744
    FEI Number
    3002771638
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    50 CHEMIN DE GASPE, COMPLEX B-5
    City
    BROMONT Quebec
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K133097

    Owner / Operator

    Firm Name
    Duoject Medical Systems
    Operator Number
    9038613
    Address
    50 chemin de Gaspe, Complex B5
    City
    Bromont
    State
    Quebec
    Postal Code
    J2L2N8
    Country
    CA
    Correspondent
    Marie-Christine Messier

    US Agent

    Business Name
    Septodont
    Contact Name
    Jessenia Castillo
    Address
    205 Granite Run Drive, Suite 150
    City
    Lancaster
    State
    PA
    ZIP
    17601
    Country
    US
    Email
    [email protected]
    Phone
    800 8728305

    Products

    Device Name Product Code
    Set, I.V. Fluid Transfer LHI

    Proprietary Names

    E-Z-Link

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility