BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    IV Clear Antimicrobial Clear Silicone Adhesive Dressing With Chlorhexidine and Silver

    Reg #: 3005004019 · FEI: 3005004019 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    COVALON TECHNOLOGIES LTD.
    Registration Number
    3005004019
    FEI Number
    3005004019
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1660 TECH AVENUE, UNIT 5
    City
    MISSISSAUGA Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K112549

    Owner / Operator

    Firm Name
    COVALON TECHNOLOGIES, INC.
    Operator Number
    9070081
    Address
    1660 TECH AVENUE, UNIT 5
    City
    MISSISSAUGA
    State
    Ontario
    Postal Code
    L4W 5S7
    Country
    CA

    US Agent

    Business Name
    COVALON TECHNOLOGIES INC
    Contact Name
    Christina Mitchell
    Address
    1200 Brickell Ave Ste 1950 # 1138
    City
    Miami
    State
    FL
    ZIP
    33131
    Country
    US
    Email
    [email protected]
    Phone
    206 5137591

    Products

    Device Name Product Code
    Dressing, Wound, Drug FRO

    Proprietary Names

    IV Clear Antimicrobial Clear Silicone Adhesive Dressing With Chlorhexidine and Silver

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility