BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    EchoConfidence

    Reg #: 3030446846 · FEI: 3030446846 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    MYCARDIUM AI LTD
    Registration Number
    3030446846
    FEI Number
    3030446846
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    The Spine Building, 2 Paddington Village
    City
    Liverpool
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K250670

    Owner / Operator

    Firm Name
    Mycardium AI Ltd
    Operator Number
    10089951
    Address
    The Spine Building, 2 Paddington Village
    City
    Liverpool
    State
    GB-LIV
    Postal Code
    L73FA
    Country
    GB
    Correspondent
    Michael G Walker

    US Agent

    Business Name
    Donawa Lifescience Inc.
    Contact Name
    Stephen Lieberman
    Address
    4545 N Ocean Boulevard, Unit 11A,
    City
    Boca Raton
    State
    FL
    ZIP
    33431
    Country
    US
    Email
    [email protected]
    Phone
    561 3020777

    Products

    Device Name Product Code
    Automated Radiological Image Processing Software QIH

    Proprietary Names

    EchoConfidence

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device