BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    EFAI Chestsuite XR Malpositioned ETT Assessment System

    Reg #: 3021032044 · FEI: 3021032044 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    EverFortune.AI Co., Ltd.
    Registration Number
    3021032044
    FEI Number
    3021032044
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8F., No. 360, Sec. 1, Jingmao Rd., Beitun Dist.
    City
    TAICHUNG CITY
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K242821

    Owner / Operator

    Firm Name
    Ever Fortune.AI Co., Ltd.
    Operator Number
    10083078
    Address
    8F., No. 360, Sec. 1, Jingmao Rd., Beitun Dist.
    City
    TAICHUNG CITY
    State
    TW-TXG
    Postal Code
    406040
    Country
    TW
    Correspondent
    RA Dept. Ever Fortune.AI

    Products

    Device Name Product Code
    Radiological Computer-Assisted Triage And Notification Software QAS

    Proprietary Names

    EFAI Chestsuite XR Malpositioned ETT Assessment System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device