BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    Thermidas IR System (ThIR-A615)

    Reg #: 3017970306 · FEI: 3017970306 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    THERMIDAS OY
    Registration Number
    3017970306
    FEI Number
    3017970306
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Polttimonkatu 4
    City
    TAMPERE Pirkanmaa
    Country
    FI

    Regulatory Submissions

    510(k) Number
    K200999

    Owner / Operator

    Firm Name
    TherMidas Oy
    Operator Number
    10080202
    Address
    Polttimonkatu 4
    City
    TAMPERE
    State
    Pirkanmaa
    Postal Code
    33210
    Country
    FI
    Correspondent
    Juha M Hamalainen

    US Agent

    Business Name
    Thermidas Americas, INC.
    Contact Name
    Juha Hamalainen
    Address
    10735 Village Club Cir N Apt 103
    City
    Saint Petersburg
    State
    FL
    ZIP
    33716
    Country
    US
    Email
    [email protected]
    Phone
    404 9938963

    Products

    Device Name Product Code
    System, Telethermographic (Adjunctive Use) LHQ

    Proprietary Names

    Thermidas IR System (ThIR-A615) Thermidas Remote SW (ThRemote) Thermidas VistaClinic Analyzer (ThAnalyzer) Thermidas IRT-384 Tablet (ThIRT-384)

    Establishment Types

    Manufacture Medical Device