BEUDAMED
    FDA Registration Active 🇨🇳 China

    Stylus LS

    Reg #: 3009265647 · FEI: 3009265647 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Kunshan Hi-Fortune Health Products Co., Ltd.
    Registration Number
    3009265647
    FEI Number
    3009265647
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    NO.625 Juxiang Road, Zhangpu Town
    City
    Kunshan City, Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K042444

    Owner / Operator

    Firm Name
    Kunshan Hi-Fortune Health Products Co., Ltd.
    Operator Number
    10036888
    Address
    NO.625 Juxiang Road, Zhangpu Town
    City
    Kunshan City
    State
    Jiangsu
    Postal Code
    215321
    Country
    CN
    Correspondent
    hongfa zhi

    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
    Wheelchair, Mechanical IOR

    Proprietary Names

    Stylus LS Stylus Litestream 500E/Litestream XF Litestream XF HD

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)