BEUDAMED
    FDA Registration Active 🇺🇸 United States

    UNBOXED INC.

    Reg #: 3038641388 · FEI: 3038641388 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    4

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    Registration Details

    Registration Name
    UNBOXED INC.
    Registration Number
    3038641388
    FEI Number
    3038641388
    Status
    Active
    Expiry Year
    2026
    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
    Unboxed Inc.
    Operator Number
    10094703
    Address
    5799 Fontanoso Way
    City
    San Jose
    State
    CA
    Postal Code
    95138
    Country
    US
    Correspondent
    Christopher Brinkmann

    Products

    Device Name Product Code
    Condom HIS
    Massager, Therapeutic, Electric ISA
    Perineometer HIR
    Cup, Menstrual HHE

    Proprietary Names

    Lelo Hex Lubricated Natural Rubber Latex Condom LELO RESPECT HEX Natural Rubber Latex Condom Banana Gold LELO Smart Wand Lelo Hex Natural Rubber Latex Condom KEGEL SMART, KEGELSMART PEARL Intimina

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198