BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Serena Sleep Night Guard

    Reg #: 3018783197 · FEI: 3018783197 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Serena Sleep
    Registration Number
    3018783197
    FEI Number
    3018783197
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    98 Saint Croix Trl N
    City
    Lakeland
    State
    MN
    ZIP
    55043
    Country
    US

    Regulatory Submissions

    510(k) Number
    K230495

    Owner / Operator

    Firm Name
    Serena Sleep
    Operator Number
    10081481
    Address
    98 St Croix Trail So
    City
    Lakeland
    State
    MN
    Postal Code
    55043
    Country
    US
    Correspondent
    Sarah Moss

    Products

    Device Name Product Code
    Mouthguard, Prescription MQC
    Mouthguard, Migraine/Tension Headache OCO

    Proprietary Names

    Serena Sleep Night Guard

    Establishment Types

    Manufacture Medical Device