BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EpiPly Sponge Skin Protectant

    Reg #: 3013833289 · FEI: 3013833289 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    OPTMED
    Registration Number
    3013833289
    FEI Number
    3013833289
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    745 Fifth Ave., Suite 500
    City
    New York
    State
    NY
    ZIP
    10151
    Country
    US

    Regulatory Submissions

    510(k) Number
    K241916

    Owner / Operator

    Firm Name
    OptMed
    Operator Number
    10058967
    Address
    745 Fifth Ave., Suite 500
    City
    New York
    State
    NY
    Postal Code
    10151
    Country
    US
    Correspondent
    Alain Klapholz

    Products

    Device Name Product Code
    Bandage, Liquid KMF

    Proprietary Names

    EpiPly Sponge Skin Protectant TearRepair Liquid Skin Protectant EpiPly Spray Skin Protectant EpiPly Wipe Skin Protectant

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility