BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    DermaScan C Ultrasonic System

    Reg #: 9613249 · FEI: 3002987034 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CORTEX TECHNOLOGY APS
    Registration Number
    9613249
    FEI Number
    3002987034
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Niels Jernes vej 6B
    City
    Aalborg Nordjylland
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K983945

    Owner / Operator

    Firm Name
    CORTEX TECHNOLOGY APS
    Operator Number
    9034314
    Address
    Niels Jernes vej 6B, --
    City
    Aalborg
    State
    Nordjylland
    Postal Code
    9220
    Country
    DK
    Correspondent
    Peter T Loekke

    US Agent

    Business Name
    CyberDerm Inc.
    Contact Name
    Mary Jo Grove
    Address
    1343 W Baltimr Pike Apt D415
    City
    Media
    State
    PA
    ZIP
    19063
    Country
    US
    Email
    [email protected]
    Phone
    610 3484152

    Products

    Device Name Product Code
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    DermaScan C Ultrasonic System

    Establishment Types

    Manufacture Medical Device