BEUDAMED
    FDA Registration Active 🇪🇸 Spain

    Leaseir MHR Xcell

    Reg #: 3023344928 · FEI: 3023344928 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    LEASEIR TECHNOLOGIES SLU
    Registration Number
    3023344928
    FEI Number
    3023344928
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Guillermo Marconi 266
    City
    Gijon Asturias
    Country
    ES

    Regulatory Submissions

    510(k) Number
    K214049

    Owner / Operator

    Firm Name
    Leaseir Technologies SLU
    Operator Number
    10085381
    Address
    Jimena Fernandez de la Vega 140 1H
    City
    Gijón
    State
    Asturias
    Postal Code
    33203
    Country
    ES
    Correspondent
    Sergio Camacho

    US Agent

    Business Name
    Paladin Medical, Inc
    Contact Name
    Elaine Duncan
    Address
    415 Valley View Trail
    City
    Houlton
    State
    WI
    ZIP
    54082
    Country
    US
    Email
    [email protected]
    Phone
    715 5496035

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    Leaseir MHR Xcell

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device