BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Vitale Collagen Dressings

    Reg #: 3007594734 · FEI: 3007594734 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CellEra, LLC
    Registration Number
    3007594734
    FEI Number
    3007594734
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1045 Reed Road, Unit C
    City
    Monroe
    State
    OH
    ZIP
    45050
    Country
    US

    Regulatory Submissions

    510(k) Number
    K040211

    Owner / Operator

    Firm Name
    CellEra, LLC
    Operator Number
    10029252
    Address
    1045 Reed Road, Unit C
    City
    Monroe
    State
    OH
    Postal Code
    45050
    Country
    US
    Correspondent
    Ken Heyl

    Products

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

    Proprietary Names

    Vitale Collagen Dressings

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198