BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Serena Sleep

    Reg #: 3018783197 · FEI: 3018783197 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Serena Sleep
    Registration Number
    3018783197
    FEI Number
    3018783197
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    592 Outpost Cir Ste H
    City
    Hudson
    State
    WI
    ZIP
    54016
    Country
    US

    Regulatory Submissions

    510(k) Number
    K203606

    Owner / Operator

    Firm Name
    Serena Sleep
    Operator Number
    10081481
    Address
    592 Outpost Circle Suite H
    City
    Hudson
    State
    WI
    Postal Code
    54016
    Country
    US
    Correspondent
    Sarah Moss

    Products

    Device Name Product Code
    Device, Anti-Snoring LRK
    Mouthguard, Prescription MQC
    Mouthguard, Migraine/Tension Headache OCO

    Proprietary Names

    Serena Sleep Ace Serena Sleep Elevate Serena Sleep Night Guard

    Establishment Types

    Manufacture Medical Device