BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OVA 1 Test

    Reg #: 3004869564 · FEI: 3004869564 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Aspira Women's Health, Inc.
    Registration Number
    3004869564
    FEI Number
    3004869564
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    12117 FM2244 #3 suite 100
    City
    Austin
    State
    TX
    ZIP
    78738
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN090004

    Owner / Operator

    Firm Name
    Aspira Women's Health
    Operator Number
    9077721
    Address
    12117 FM2244 #3 suite 100
    City
    Austin
    State
    TX
    Postal Code
    78738
    Country
    US
    Correspondent
    Silvana Franco

    Products

    Device Name Product Code
    Ovarian Adnexal Mass Assessment Score Test System ONX

    Proprietary Names

    OVA 1 Test

    Establishment Types

    Manufacture Medical Device