BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Guardenia

    Reg #: 9616720 · FEI: 3003283598 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ADVANCED SURGICAL CONCEPTS (ASC)
    Registration Number
    9616720
    FEI Number
    3003283598
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    UNIT 4, SUNNYBANK CENTRE
    City
    BRAY Wicklow
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K232701

    Owner / Operator

    Firm Name
    Advanced Surgical Concepts Limited
    Operator Number
    9039366
    Address
    Sunnybank Centre, Upper Dargle Road
    City
    Bray
    State
    Wicklow
    Postal Code
    --
    Country
    IE

    US Agent

    Business Name
    Gyrus ACMI, Inc.
    Contact Name
    Todd Brill
    Address
    800 West Park Drive, --
    City
    Westborough
    State
    MA
    ZIP
    01581
    Country
    US
    Email
    [email protected]
    Phone
    508 2077661

    Products

    Device Name Product Code
    Laparoscope, General & Plastic Surgery GCJ

    Proprietary Names

    Guardenia

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility