BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    PILSON DIRECT TRADING LIMITED

    Reg #: 3011763071 · FEI: 3011763071 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    7

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    Registration Details

    Registration Name
    PILSON DIRECT TRADING LIMITED
    Registration Number
    3011763071
    FEI Number
    3011763071
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    25 Thames Street, Gateshead
    City
    Newcastle Newcastle upon Tyne
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K061682

    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 Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Biopsy Needle Guide Kit OIJ
    Catheter, Ultrasound, Intravascular OBJ
    Automated Radiological Image Processing Software QIH
    Apparatus, Exhaust, Surgical FYD

    Proprietary Names

    Voluson E8 Ultrasound systems and accessories / transducers ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM AND ACCESSORIES ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNER HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS AND TRANSDUCERS ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System EPIQ CVX , EPIQ 5, EPIQ 7, EPIQ Elite, Affiniti 30, Affiniti 50, Affiniti 70 Ultrasound System and accessories EPIQ Cvx and Series Diagnostic Ultrasound System; Affiniti Cvx and Series Diagnostic Ultrasound System Philips EPIQ CVX /EPIQ 7G/ EPIQ 7C/ EPIQ 5 Diagnostic Ultrasound System VOLUSON I/E AND TRANSDUCERS GE Ultrasound Transducers NEPTUNE WASTE MANAGEMENT STSTEM AND ACCESSORIES M5 DIAGNOSTIC ULTRASOUND SYSTEM AND ACCESSORIES BK500, BK3500, BK3000 Ultrasound system

    Establishment Types

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