BEUDAMED
    FDA Registration Active 🇨🇳 China

    XIAMEN YIZHOU IMP. & EXP. CO., LTD.

    Reg #: 3008763803 · FEI: 3008763803 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    34
    Establishment Types
    3
    Classifications
    10

    Registration Details

    Registration Name
    XIAMEN YIZHOU IMP. & EXP. CO., LTD.
    Registration Number
    3008763803
    FEI Number
    3008763803
    Status
    Active
    Expiry Year
    2026
    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
    Tray, Impression, Preformed EHY
    Accessories, Implant, Dental, Endosseous NDP
    Device, Anti-Snoring LRK
    Retractor, All Types EIG
    Device, Jaw Repositioning LQZ
    Dilator, Nasal LWF
    Disinfectant, Medical Devices LRJ
    Mouthguard, Over-The-Counter OBR
    Heat Source For Bleaching Teeth EEG
    Protector, Dental BRW

    Proprietary Names

    Impression Mouth Tray(For grinding,TeethWhitening) Anti Snore Mouth Tray Mouthguard plastic case SilentZPro 2 Cheek Retractor Tranquility Pro 2 Tranquility PRO Anti-Snoring Mouth Guard Serenity Pro 2 Eliminator Pro 2 Somnos Anti-Snoring Mouth Guard Somnos Pro 2 Tranquility Tranquility PRO Tranquility Anti-Snoring Mouth Guard Intelliguard Pro Tranquility PRO 2 Anti-Snoring Mouth Guard Bright Guard Pro 2 Nasal Dilator Eliminator Box Bright Guard The ConfiDental Moldable Mouth Guard for Teeth Grinding The ConfiDental Anti Grinding Guard ClenchNoMore Anti Grinding Guard moldable mouth guard for teeth grinding TheSleepGuard Honeybull Mouth Guard for Teeth Grinding Stafenit Mouth Guard,LOPIANY Mouth Guard,Litlcutie Anti Grinding Guard LIFEWAY Mouth Guard GRINDSHIELD Mouth Guard for Teeth Grinding UNIEDI Mouth Guard teeth whitening LED light;teeth whitening light; teeth whitening mouth tray LED light;teeth whitening accelerator GuardianZPro

    Establishment Types

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