BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AEYE-DS

    Reg #: 3025301728 · FEI: 3025301728 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    AEYE HEALTH INC.
    Registration Number
    3025301728
    FEI Number
    3025301728
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1501 Broadway (Suite #12014)
    City
    New York
    State
    NY
    ZIP
    10036
    Country
    US

    Regulatory Submissions

    510(k) Number
    K240058

    Owner / Operator

    Firm Name
    AEYE Health Inc.
    Operator Number
    10086693
    Address
    1501 Broadway (Suite #12014)
    City
    New York
    State
    NY
    Postal Code
    10036
    Country
    US
    Correspondent
    Zack Dvey-Aharon, PhD

    Products

    Device Name Product Code
    Diabetic Retinopathy Detection Device PIB

    Proprietary Names

    AEYE-DS

    Establishment Types

    Manufacture Medical Device