BEUDAMED
    FDA Registration Active 🇨🇳 China

    JIANGXI ROYALL SMART TECHNOLOGY CO., LTD.

    Reg #: 3026164517 · FEI: 3026164517 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    JIANGXI ROYALL SMART TECHNOLOGY CO., LTD.
    Registration Number
    3026164517
    FEI Number
    3026164517
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Building 1, 2nd-3rd Floor and Building 3, 2nd Floor, Lefeng Technology Park, Northern Area, Huangbu Industrial Park, Shangyou County
    City
    Ganzhou Jiangxi
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K230443

    Owner / Operator

    Firm Name
    Jiangxi Royall Smart Technology Co., Ltd.
    Operator Number
    10086681
    Address
    Building 1, 2nd-3rd Floor and Building 3, 2nd Floor, Lefeng Technology Park, Northern Area, Huangbu Industrial Park, Shangyou County
    City
    Ganzhou
    State
    Jiangxi
    Postal Code
    341200
    Country
    CN
    Correspondent
    Yuheng Huang

    US Agent

    Business Name
    SHARE INFO INC.
    Contact Name
    Clare Ho
    Address
    3357 158th St Flushing, NY
    City
    Flushing
    State
    NY
    ZIP
    11358
    Country
    US
    Email
    [email protected]
    Phone
    929 4102964

    Products

    Device Name Product Code
    Toothbrush, Powered JEQ
    Stimulator, Nerve, Transcutaneous, Over-The-Counter NUH
    Stimulator, Muscle, Powered, For Muscle Conditioning NGX
    Stimulator, Electrical, Transcutaneous, For Arthritis NYN
    Unit, Oral Irrigation EFS

    Proprietary Names

    Sonic Electric Toothbrush (model: YM3) Sonic Electric Toothbrush (model: YM502(W), YM502(B), YM502(E), TBM10T, TBM11T, LY-T01) Sonic Electric Toothbrush (model: YM6(W), YM6(B), YM6(E), YM6Pro(W), YM6Pro(B), YM6Pro(E)) Sonic Electric Toothbrush (model: YM3(W)) TENS & EMS Device (Model: LY-ET-01, LY-ET-02, LY-ET-04) Oral Irrigator (Model: C2, C5, C6) Water flosser (model: CL1, CL2, CL1(W), CL2(W))

    Establishment Types

    Manufacture Medical Device