BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Resistat Wrapper

    Reg #: 3007289408 · FEI: 3007289408 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Medline Canada
    Registration Number
    3007289408
    FEI Number
    3007289408
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    995 Southgate Road
    City
    Guelph Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K003755

    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
    Drape, Surgical KKX
    Gown, Surgical FYA

    Proprietary Names

    Resistat Wrapper MEDLINE BLOCKADE OR RESISTAT SURGICAL GOWNS AND SURGICAL DRAPES

    Establishment Types

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