BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Medline International B.V.

    Reg #: 3014499739 · FEI: 3014499739 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    32
    Establishment Types
    1
    Classifications
    11

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    Registration Details

    Registration Name
    Medline International B.V.
    Registration Number
    3014499739
    FEI Number
    3014499739
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    (147186-D), D37C, Jalan DPB3, Pelabuhan Tanjung Pelepas
    City
    Gelang Patah Johor
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K922410

    Owner / Operator

    Firm Name
    Medline Industries, LP
    Operator Number
    1417592
    Address
    Three Lakes Drive
    City
    Northfield
    State
    IL
    Postal Code
    60093
    Country
    US
    Correspondent
    Stephanie Augsburg

    US Agent

    Business Name
    Simcon International LLC
    Contact Name
    Rosanna Lee
    Address
    1200 Townline Rd
    City
    Mundelein
    State
    IL
    ZIP
    60060
    Country
    US
    Email
    [email protected]
    Phone
    847 9492290

    Products

    Device Name Product Code
    Wire, Guide, Catheter DQX
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
    Set, Tubing And Support, Ventilator (W Harness) BZO
    Mask, Oxygen, Non-Rebreathing KGB
    Ventilator, Non-Continuous (Respirator) BZD
    Mask, Oxygen BYG
    Nebulizer (Direct Patient Interface) CAF
    Catheter, Intravascular, Diagnostic DQO
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Tubing, Pressure And Accessories BYX
    Monitor, Line Isolation DRI

    Proprietary Names

    AVENUE Insertion Tool NAMIC MLL-RA Adaptor NAMIC Manifold Clamp NAMIC Standard Peripheral Vascular Angiographic Kit NAMIC Angiographic Pressure Monitoring Manifolds NAMIC Angiographic Manifold NAMIC Standard Angiographic Kit NAMIC Stopcock Medline Ventilator Tubing Medline Hudson RCI CORR-A-FLEX Corrugated Tubing NAMIC Port Protector Medline Hudson RCI Face Tent Medline Tracheostomy Mask Medline Oxygen Mask Medline Hudson RCI High-Concentration Oxygen Masks Hudson RCI High Concentration Oxygen Mask NAMIC Contrast Injection Line Medline Hudson RCI Tee Adapter Medline Pressure Tubing and Accessories Medline Pressure Monitoring Tubing Medline Aerosol Tubing Dynacor Oxygen Connecting Tube Hudson RCI Oxygen Supply Tubing Connector Medline Christmas Tree Style Nut and Nipple Adapter NAMIC Tri-Adaptor NAMIC Y-Adaptor NAMIC Tri-Adaptor Kit NAMIC Y-Adaptor Kit Medline Hudson Micro Mist Nebulizer NAMIC Pediatric Pressure Monitoring Lines NAMIC Adaptor NAMIC Pressure Monitoring Lines

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device