BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Acticoat™ Flex Barrier Dressing

    Reg #: 3023287212 · FEI: 3023287212 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    C6 MEDICAL INCORPORATED (MEDNEEDLES & ADVWOUNDCARE)
    Registration Number
    3023287212
    FEI Number
    3023287212
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    43 Church Street, Suite 300
    City
    St Catharines Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K083113

    Owner / Operator

    Firm Name
    MEDNEEDLES & ADVWOUNDCARE USA
    Operator Number
    10085928
    Address
    296 Collier Rd, Building 2 Unit 5
    City
    Thorold
    State
    Ontario
    Postal Code
    L2V 5B6
    Country
    CA
    Correspondent
    Didi Mukendi

    Products

    Device Name Product Code
    Dressing, Wound, Drug FRO

    Proprietary Names

    Acticoat™ Flex Barrier Dressing

    Establishment Types

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