BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Flexi-Seal FMS Collection Bags

    Reg #: 3012881740 · FEI: 3012881740 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ConvaTec Canada Ltd.
    Registration Number
    3012881740
    FEI Number
    3012881740
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1425 TransCanada Highway, Suite 100
    City
    Dorval Quebec
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K112342

    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
    Courtney Smith

    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
    239 7762947

    Products

    Device Name Product Code
    Tubes, Gastrointestinal (And Accessories) KNT

    Proprietary Names

    Flexi-Seal FMS Collection Bags Flexi-Seal SIGNAL Fecal Management System

    Establishment Types

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