BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    GigaLaser

    Reg #: 3003889343 · FEI: 3003889343 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    POWERMEDIC APS
    Registration Number
    3003889343
    FEI Number
    3003889343
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8 Gasvaerksvej
    City
    HOLBAEK Sjalland
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K134017

    Owner / Operator

    Firm Name
    POWERMEDIC APS
    Operator Number
    9052408
    Address
    GASVAERKSVEJ 8, --
    City
    HOLBAEK
    State
    DK-NOTA
    Postal Code
    DK-4300
    Country
    DK
    Correspondent
    ARNE - GRINSTED

    US Agent

    Business Name
    POWERMEDIC US, Inc.
    Contact Name
    Maja Grinsted Hillegass
    Address
    114 FS Drive, Suite A
    City
    Viroqua
    State
    WI
    ZIP
    54665
    Country
    US
    Email
    [email protected]
    Phone
    608 4062020

    Products

    Device Name Product Code
    Lamp, Infrared, Therapeutic Heating ILY

    Proprietary Names

    GigaLaser

    Establishment Types

    Manufacture Medical Device