BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    TRANBERG Thermoguide Therapy System

    Reg #: 3012452798 · FEI: 3012452798 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    CLINICAL LASERTHERMIA SYSTEMS AB
    Registration Number
    3012452798
    FEI Number
    3012452798
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Scheelevagen 2
    City
    Lund Skane
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K214125

    Owner / Operator

    Firm Name
    Clinical Laserthermia Systems AB
    Operator Number
    10050452
    Address
    Scheelevagen 2
    City
    Lund
    State
    Skane
    Postal Code
    22381
    Country
    SE
    Correspondent
    Lars-Erik Eriksson

    US Agent

    Business Name
    OMEDtech, LLC
    Contact Name
    David Makanani
    Address
    8501 Lullwater Dr, # 1208
    City
    Dallas
    State
    TX
    ZIP
    75238
    Country
    US
    Email
    [email protected]
    Phone
    405 8260713

    Products

    Device Name Product Code
    Neurosurgical Laser With Mr Thermography ONO

    Proprietary Names

    TRANBERG Thermoguide Therapy System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device