BEUDAMED
    FDA Registration Active 🇨🇳 China

    Serenity Pro 2

    Reg #: 3008763803 · FEI: 3008763803 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    12
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    XIAMEN YIZHOU IMP. & EXP. CO., LTD.
    Registration Number
    3008763803
    FEI Number
    3008763803
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    201,2F,Huili Industrial Park,Meixi Rd.,Tong An District,
    City
    Xiamen Fujian
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K201484

    Owner / Operator

    Firm Name
    Xiamen Yizhou Imp. & Exp. Co., Ltd.
    Operator Number
    10053196
    Address
    201,2F,Huili Industrial Park,Meixi Rd.,Tong An District,
    City
    Xiamen
    State
    Fujian
    Postal Code
    361100
    Country
    CN
    Correspondent
    Elaine Huang

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    Device, Jaw Repositioning LQZ
    Device, Anti-Snoring LRK

    Proprietary Names

    Serenity Pro 2 Somnos Anti-Snoring Mouth Guard Tranquility Pro 2 Tranquility PRO Anti-Snoring Mouth Guard Bright Guard Pro 2 Tranquility Anti-Snoring Mouth Guard Tranquility Somnos Pro 2 Intelliguard Pro Tranquility PRO 2 Anti-Snoring Mouth Guard Tranquility PRO Eliminator Pro 2

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device