BEUDAMED
    FDA Registration Active 🇬🇷 Greece

    SONOSCAPE

    Reg #: 3014271642 · FEI: 3014271642 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    DORMED HELLAS SA
    Registration Number
    3014271642
    FEI Number
    3014271642
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Kleanthous 10 str
    City
    Thessaloniki Kentriki Makedonia
    Country
    GR

    Regulatory Submissions

    510(k) Number
    K131937

    Owner / Operator

    Firm Name
    DORMED HELLAS SA
    Operator Number
    10092523
    Address
    Kleanthous 10 str
    City
    Thessaloniki
    State
    Kentriki Makedonia
    Postal Code
    54642
    Country
    GR
    Correspondent
    ATHANASIOS XILOPINAKAS

    US Agent

    Business Name
    The Wood Burditt Group
    Contact Name
    Richard Chun
    Address
    10 E. Sranton Avenue, Su. 201
    City
    Lake Bluff
    State
    IL
    ZIP
    60044
    Country
    US
    Email
    [email protected]
    Phone
    847 2347500 ext. 204

    Products

    Device Name Product Code
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX

    Proprietary Names

    SONOSCAPE

    Establishment Types

    Repack or Relabel Medical Device Export Device to the United States But Perform No Other Operation on Device