BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Lelo Hex Lubricated Natural Rubber Latex Condom 12s

    Reg #: 3006317264 · FEI: 3006317264 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    LELO USA INC.
    Registration Number
    3006317264
    FEI Number
    3006317264
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    5799 Fontanoso Way
    City
    San Jose
    State
    CA
    ZIP
    95138
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243421

    Owner / Operator

    Firm Name
    Sedic
    Operator Number
    10036125
    Address
    5799 Fontanoso Way
    City
    San Jose
    State
    CA
    Postal Code
    95138
    Country
    US
    Correspondent
    Pavle Sedic

    Products

    Device Name Product Code
    Condom HIS

    Proprietary Names

    Lelo Hex Lubricated Natural Rubber Latex Condom 12s Lelo Hex Lubricated Natural Rubber Latex Condom 3s Lelo Hex Lubricated Natural Rubber Latex Condom 36s

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device