BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    ePulse

    Reg #: 3007353760 · FEI: 3007353760 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ENERGIST LIMITED
    Registration Number
    3007353760
    FEI Number
    3007353760
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2 Park Pavilions, Clos Llyn Cwm, Enterprise Park
    City
    Swansea
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K040156

    Owner / Operator

    Firm Name
    Energist Limited
    Operator Number
    10027469
    Address
    2 Park Pavilions, Clos Llyn Cwm, Enterprise Park
    City
    Swansea
    State
    GB-SWA
    Postal Code
    SA6 8QY
    Country
    GB

    US Agent

    Business Name
    QA/RA Consulting Group, Inc.
    Contact Name
    Scott Bednar
    Address
    3335 Tuscarawas Road
    City
    Beaver
    State
    PA
    ZIP
    15009
    Country
    US
    Email
    [email protected]
    Phone
    412 4188066

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    ePulse IFL Professional system C100 i200+ i300

    Establishment Types

    Manufacture Medical Device