BEUDAMED
    FDA Registration Active 🇮🇸 Iceland

    KERECIS EHF

    Reg #: 3016429246 · FEI: 3016429246 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    42
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    KERECIS EHF
    Registration Number
    3016429246
    FEI Number
    3016429246
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Sundstraeti 38
    City
    Isafjordur Vestfiroir
    Country
    IS

    Regulatory Submissions

    510(k) Number
    K213231

    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
    Brynjar Arnarson
    Address
    2300 Clarendon Boulvard,, Suite 1210
    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
    Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery OXH
    Mesh, Surgical FTM
    Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon OWY

    Proprietary Names

    Shield Adhesive Kerecis Shield Adhesive Shield Kerecis Shield Standard Kerecis SurgiClose SurgiClose Silicone Kerecis Shield Kerecis SurgiClose Silicone Kerecis Shield Spiral Shield Standard MariGen Shield Kerecis Omega3 MariGen Shield Shield Spiral Kerecis MariGen Shield SurgiClose Kerecis Omega3 SurgiBind SurgiBind SurgiBind Tendon Protect Kerecis Omega3 OR MariGen Wound Extra Kerecis Omega3 Burn SurgiClose Micro Kerecis Omega3 SurgiClose Kerecis Omega3 SurgiClose Micro Kerecis Omega3 GraftGuide Kerecis Omega3 MicroGraft GraftGuide GraftGuide Mano Mano GraftGuide Micro Kerecis Omega3 Wound MariGen Alphaplex with MariGen Wound Marigen Omega3 Kerecis Omega3 Marigen Omega3 Wound MariGen Wound Kerecis Omega3 MariGen Expanse Marigen Micro MariGen Expanse Kerecis Omega3 MariGen Kerecis Omega3 MariGen Micro

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198