BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    EPIQ CVX , EPIQ 5, EPIQ 7, EPIQ Elite, Affiniti 30, Affiniti 50, Affiniti 70 Ultrasound System and accessories

    Reg #: 3011763071 · FEI: 3011763071 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    PILSON DIRECT TRADING LIMITED
    Registration Number
    3011763071
    FEI Number
    3011763071
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    25 Thames Street, Gateshead
    City
    Newcastle Newcastle upon Tyne
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K181485

    Owner / Operator

    Firm Name
    Pilson Direct Trading Limited
    Operator Number
    10049953
    Address
    25 Thames Street, Gateshead
    City
    Newcastle
    State
    Newcastle upon Tyne
    Postal Code
    NE8 3SP
    Country
    GB
    Correspondent
    Elvira Pili

    US Agent

    Business Name
    The Wood Burditt Group
    Contact Name
    Richard Chun
    Address
    10 E. Scranton Avenue, Suite 201, Lake Bluff, Lake Bluff,
    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 Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX

    Proprietary Names

    EPIQ CVX , EPIQ 5, EPIQ 7, EPIQ Elite, Affiniti 30, Affiniti 50, Affiniti 70 Ultrasound System and accessories

    Establishment Types

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