BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    EU-ME2

    Reg #: 3012393058 · FEI: 3012393058 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    BMEDICAL APS
    Registration Number
    3012393058
    FEI Number
    3012393058
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    vejlen 31
    City
    Vadum Nordjylland
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K203128

    Owner / Operator

    Firm Name
    bmedical aps
    Operator Number
    10083675
    Address
    vejlen 31
    City
    Vadum
    State
    Nordjylland
    Postal Code
    9430
    Country
    DK
    Correspondent
    mehdi smail

    US Agent

    Business Name
    Collaborative medical solutions
    Contact Name
    Trey McIntyre
    Address
    4134 Birkshire Heights
    City
    Fort Mill
    State
    SC
    ZIP
    29708
    Country
    US
    Email
    [email protected]
    Phone
    704 4180209

    Products

    Device Name Product Code
    Endoscopic Ultrasound System, Gastroenterology-Urology ODG
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX

    Proprietary Names

    EU-ME2

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device