BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    EchoGo Pro

    Reg #: 3016585383 · FEI: 3016585383 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ULTROMICS, LTD.
    Registration Number
    3016585383
    FEI Number
    3016585383
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4630 Kingsgate, Cascade Way, Oxford Business Park South
    City
    Oxford Oxfordshire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K201555

    Owner / Operator

    Firm Name
    Ultromics, Ltd.
    Operator Number
    10062539
    Address
    4630 Kingsgate, Cascade Way, Oxford Business Park South
    City
    Oxford
    State
    Oxfordshire
    Postal Code
    OX4 2SU
    Country
    GB
    Correspondent
    Jaco Jacobs

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer POK

    Proprietary Names

    EchoGo Pro

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device