BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Siemens S1000, S2000, S3000

    Reg #: 3013844297 · FEI: 3013844297 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    DANELIS MEDICAL LIMITED
    Registration Number
    3013844297
    FEI Number
    3013844297
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    The Hollies, Bryngwy
    City
    Rhayader Powys
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K081148

    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
    RW Medical Imaging Parts LLC
    Contact Name
    Ray Wayt
    Address
    2031 SW Newport Isles Boulevard
    City
    Port St Lucie
    State
    FL
    ZIP
    34953
    Country
    US
    Email
    [email protected]
    Phone
    330 2576604

    Products

    Device Name Product Code
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Doppler, Ultrasonic IYN

    Proprietary Names

    Siemens S1000, S2000, S3000

    Establishment Types

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