BEUDAMED
    FDA Registration Active 🇺🇸 United States

    LUJENA, INC.

    Reg #: 3029582858 · FEI: 3029582858 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

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    Registration Details

    Registration Name
    LUJENA, INC.
    Registration Number
    3029582858
    FEI Number
    3029582858
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    11447 Rolling Hills Dr.
    City
    El Cajon
    State
    CA
    ZIP
    92020
    Country
    US

    Regulatory Submissions

    510(k) Number
    K222492

    Owner / Operator

    Firm Name
    Lujena, Inc.
    Operator Number
    10088889
    Address
    11447 Rolling Hills Dr.
    City
    El Cajon
    State
    CA
    Postal Code
    92020
    Country
    US
    Correspondent
    Troy Gemmer

    Products

    Device Name Product Code
    Dilator, Vaginal HDX

    Proprietary Names

    Hope&Her Vaginal Dilators

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility