BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Water-Jel Technologies, LLC

    Reg #: 1219592 · FEI: 1219592 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    Water-Jel Technologies, LLC
    Registration Number
    1219592
    FEI Number
    1219592
    Status
    Active
    Expiry Year
    2026
    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
    Sheet, Burn FPY
    Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic MGQ
    Dressing, Wound, Hydrogel Without Drug And/Or Biologic NAE

    Proprietary Names

    Water-Jel First Responder HA Water-Jel Military Water-Jel Tactical BurnFree Burn Jel Plus Cool Jel Wound Gel Water-Jel First Responder

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility