BEUDAMED
    FDA Registration Active 🇮🇸 Iceland

    Kerecis Omega3 Burn

    Reg #: 3010600625 · FEI: 3010600625 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    13
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    KERECIS EHF
    Registration Number
    3010600625
    FEI Number
    3010600625
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Eyrargata 2
    City
    Isafjordur Vestfiroir
    Country
    IS

    Regulatory Submissions

    510(k) Number
    K190528

    Owner / Operator

    Firm Name
    Kerecis ehf
    Operator Number
    10045392
    Address
    Eyrargata 2
    City
    Isafjordur
    State
    Vestfiroir
    Postal Code
    400
    Country
    IS

    US Agent

    Business Name
    Kerecis LLC
    Contact Name
    Skuli Magnusson
    Address
    2101 Wilson Blvd Ste 900
    City
    Arlington
    State
    VA
    ZIP
    22201
    Country
    US
    Email
    [email protected]
    Phone
    703 2878752

    Products

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

    Proprietary Names

    Kerecis Omega3 Burn Kerecis Omega3 OR MariGen Wound Extra Kerecis Omega3 GraftGuide Kerecis Omega3 SurgiClose SurgiClose Kerecis Omega3 SurgiClose Micro SurgiClose Micro GraftGuide Kerecis Omega3 MicroGraft GraftGuide Micro GraftGuide Mano Mano

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device