BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Digital Diagnostics Inc.

    Reg #: 3014579028 · FEI: 3014579028 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Digital Diagnostics Inc.
    Registration Number
    3014579028
    FEI Number
    3014579028
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    210 5th Street, Suite 103
    City
    Coralville
    State
    IA
    ZIP
    52241
    Country
    US

    Regulatory Submissions

    510(k) Number
    K213037

    Owner / Operator

    Firm Name
    Digital Diagnostics Inc.
    Operator Number
    10058009
    Address
    210 5th Street, Suite 103
    City
    Coralville
    State
    IA
    Postal Code
    52241
    Country
    US
    Correspondent
    Luke Miller

    Products

    Device Name Product Code
    Diabetic Retinopathy Detection Device PIB

    Proprietary Names

    LumineticsCore IDx-DR

    Establishment Types

    Manufacture Medical Device