BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ECM3 Collagen Sheet Dressing

    Reg #: 3012973796 · FEI: 3012973796 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MAIDEN BIOSCIENCES
    Registration Number
    3012973796
    FEI Number
    3012973796
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    101 Lakeforest Blvd., Suite 390
    City
    Gaithersburg
    State
    MD
    ZIP
    20877
    Country
    US

    Regulatory Submissions

    510(k) Number
    K213598

    Owner / Operator

    Firm Name
    Maiden Biosciences, Inc.
    Operator Number
    10052710
    Address
    101 Lakeforest Blvd., Suite 390
    City
    Gaithersburg
    State
    MD
    Postal Code
    20877
    Country
    US
    Correspondent
    Mark Gorman

    Products

    Device Name Product Code
    Wound Dressing With Animal-Derived Material(S) KGN

    Proprietary Names

    ECM3 Collagen Sheet Dressing

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198