BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    MYCARDIUM AI LTD

    Reg #: 3030446846 · FEI: 3030446846 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    MYCARDIUM AI LTD
    Registration Number
    3030446846
    FEI Number
    3030446846
    Status
    Active
    Expiry Year
    2026
    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
    Ranjitha Byatha Kemparaj

    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
    System, Digital Image Communications, Radiological LMD
    System, Image Processing, Radiological LLZ

    Proprietary Names

    EchoConfidence 1CMR Lite 1CMR Pro

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198