BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Wound Gel

    Reg #: 1219592 · FEI: 1219592 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Water-Jel Technologies, LLC
    Registration Number
    1219592
    FEI Number
    1219592
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    13359 Reese Blvd. E
    City
    Huntersville
    State
    NC
    ZIP
    28078
    Country
    US

    Regulatory Submissions

    510(k) Number
    K003396

    Owner / Operator

    Firm Name
    Safeguard US Holdco INC
    Operator Number
    1219592
    Address
    13359 Reese Blvd. E
    City
    Huntersville
    State
    NC
    Postal Code
    28078
    Country
    US
    Correspondent
    Kimberly Reed

    Products

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

    Proprietary Names

    Wound Gel Burn Jel Plus Cool Jel

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility