BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MAI/GENESIS

    Reg #: 3003697955 · FEI: 3003697955 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    MAI/GENESIS
    Registration Number
    3003697955
    FEI Number
    3003697955
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    605 Pro-Ject Drive
    City
    ELMWOOD
    State
    WI
    ZIP
    54740
    Country
    US

    Regulatory Submissions

    510(k) Number
    K962828

    Owner / Operator

    Firm Name
    GENESIS INDUSTRIES, INC.
    Operator Number
    2183741
    Address
    303 SOUTH MCKAY AVE.,, P.O. BOX 39
    City
    SPRING VALLEY
    State
    WI
    Postal Code
    54767
    Country
    US

    Products

    Device Name Product Code
    Applicator, Vaginal HGD
    Pump, Breast, Non-Powered HGY

    Proprietary Names

    QUAD-TIP VAGINAL APPLICATOR EVERT-IT

    Establishment Types

    Manufacture Medical Device