BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    ULTROMICS, LTD.

    Reg #: 3016585383 · FEI: 3016585383 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    ULTROMICS, LTD.
    Registration Number
    3016585383
    FEI Number
    3016585383
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4630 Kingsgate, Cascade Way, Oxford Business Park South
    City
    Oxford Oxfordshire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K213275

    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
    Automated Radiological Image Processing Software QIH
    Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer POK
    Adjunctive Heart Failure Status Indicator QUO
    Adjunctive Cardiac Amyloidosis Status Indicator SDJ
    System, Digital Image Communications, Radiological LMD

    Proprietary Names

    EchoGo Core EchoGo Pro EchoGo Heart Failure (2) EchoGo Amyloidosis (1) EchoGo WorkStream (1) EchoGo Heart Failure

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198