BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    Sunrise system

    Reg #: 3022505448 · FEI: 3022505448 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SUNRISE SA
    Registration Number
    3022505448
    FEI Number
    3022505448
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Chaussee de marche 598 boite 2
    City
    NAMUR
    Country
    BE

    Regulatory Submissions

    510(k) Number
    DEN210015

    Owner / Operator

    Firm Name
    SUNRISE
    Operator Number
    10084974
    Address
    Chaussee de Marche 598 boite 2
    City
    Namur
    State
    BE-WNA
    Postal Code
    5101
    Country
    BE
    Correspondent
    Cecile Roy

    US Agent

    Business Name
    Qserve Group US, Inc.
    Contact Name
    Mindy McCann
    Address
    350 S. Main Street Suite 309
    City
    Doylestown
    State
    PA
    ZIP
    18901
    Country
    US
    Email
    [email protected]
    Phone
    424 2718169

    Products

    Device Name Product Code
    Device For Sleep Apnea Testing Based On Mandibular Movement QRS

    Proprietary Names

    Sunrise system

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198