BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    DANELIS MEDICAL LIMITED

    Reg #: 3013844297 · FEI: 3013844297 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    15
    Establishment Types
    1
    Classifications
    7

    Registration Details

    Registration Name
    DANELIS MEDICAL LIMITED
    Registration Number
    3013844297
    FEI Number
    3013844297
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    The Hollies, Bryngwy
    City
    Rhayader Powys
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K240704

    Owner / Operator

    Firm Name
    Danelis Medical Limited
    Operator Number
    10061863
    Address
    The Hollies, Bryngwy
    City
    Rhayader
    State
    Powys
    Postal Code
    LD6 5BN
    Country
    GB
    Correspondent
    John Williams

    US Agent

    Business Name
    Anskar Medical Group
    Contact Name
    Bob Potokar
    Address
    5612 Reef Rd
    City
    Mentor
    State
    OH
    ZIP
    44060
    Country
    US
    Email
    [email protected]
    Phone
    216 4036614

    Products

    Device Name Product Code
    Transducer, Ultrasonic, Diagnostic ITX
    Automated Radiological Image Processing Software QIH
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Catheter, Ultrasound, Intravascular OBJ
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Biopsy Needle Guide Kit OIJ
    System, Image Processing, Radiological LLZ

    Proprietary Names

    Sequoia LOGIQ E10 HM70A Siemens S1000, S2000, S3000 BK5000 Samsung RS80A Xporte 6VT-D MTurbo Philips CX30/CX50 Noblus Philips Epiq 7/5/CVx Affiniti 70/50/30 Toshiba Aplio 500/400/300 Canon Aplio i series GE LOGIQ E9 LOGIQ E9 XDClear 2

    Establishment Types

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