BEUDAMED
    FDA Registration Active 🇿🇦 South Africa

    BURNEEZE, BURNFREE, MEDIBURN,

    Reg #: 8044046 · FEI: 3010598187 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BURNSHIELD (PTY) LTD.
    Registration Number
    8044046
    FEI Number
    3010598187
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1 Manchester Road, Medopark Block 3
    City
    Wadeville Gauteng
    Country
    ZA

    Regulatory Submissions

    510(k) Number
    K943728

    Owner / Operator

    Firm Name
    Burnshield (Pty) Ltd.
    Operator Number
    9052084
    Address
    1 Manchester Road, Medopark Block 3
    City
    Wadeville
    State
    ZA-NOTA
    Postal Code
    1428
    Country
    ZA

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic MGQ

    Proprietary Names

    BURNEEZE, BURNFREE, MEDIBURN, BURNSOOTHE, BURNSHIELD HYDROGEL BURN BLOTS ARAMARK Everone Be Smart Get Prepared

    Establishment Types

    Manufacture Medical Device