BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    ConvaTec Canada Ltd.

    Reg #: 3012881740 · FEI: 3012881740 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    27
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    ConvaTec Canada Ltd.
    Registration Number
    3012881740
    FEI Number
    3012881740
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1425 TransCanada Highway, Suite 100
    City
    Dorval Quebec
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K162906

    Owner / Operator

    Firm Name
    ConvaTec
    Operator Number
    2241599
    Address
    7815 National Service Road, Suite 600
    City
    Greensboro
    State
    NC
    Postal Code
    27409
    Country
    US
    Correspondent
    Jared Ragone

    US Agent

    Business Name
    ConvaTec
    Contact Name
    Courtney Smith
    Address
    20 Maguire
    City
    Lexington, MA
    State
    MA
    ZIP
    03841
    Country
    US
    Email
    [email protected]
    Phone
    603 2470255

    Products

    Device Name Product Code
    Tubes, Gastrointestinal (And Accessories) KNT
    Gastrointestinal Tubes With Enteral Specific Connectors PIF
    Dressing, Wound, Hydrophilic NAC

    Proprietary Names

    Flexi-Seal PROTECT Fecal Management System with ENFIT Flexi-Seal PROTECT Fecal Management System Flexi-Seal FMS Collection Bags Flexi-Seal SIGNAL Fecal Management System Flexi-Seal SIGNAL Fecal Management System with Odor Barrier Flexi-Seal PROTECT FMS with Luer Connector Flexi-Seal PROTECT FMS with EnFit Connector Flexi-Seal Fecal Management System CombiDERM Non-Adhesive Sterile Dressing AQUACEL Surgical ConvaFoam Silicone ConvaFoam Border CombiDERM ACD Sterile Dressing KALTOSTAT Alginate ConvaMax SUPERABSORBER Versiva AQUACEL Burn Aquacel ConvaFiber CarboFlex Versiva XC Adhesive Versiva XC Non-adhesive ConvaFoam Non-Adhesive AQUACEL Hydrofiber AQUACEL Foam AQUACEL Extra AQUACEL Extra Hydrofiber Dressing AQUACEL Foam Pro

    Establishment Types

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