BEUDAMED
    FDA Registration Active 🇨🇳 China

    Single-use Video Ureterorenoscope (Model: SVU-220US)

    Reg #: 3014691548 · FEI: 3014691548 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    HUGER MEDICAL INSTRUMENT CO., LTD.
    Registration Number
    3014691548
    FEI Number
    3014691548
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Building 26A, No. 3825, Xinzhuan Highway, Dongjing Town, Songjiang District
    City
    Shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K241639

    Owner / Operator

    Firm Name
    HUGER Medical Instrument Co., Ltd.
    Operator Number
    10091914
    Address
    Building 26A, No. 3825, Xinzhuan Highway, Dongjing Town, Songjiang District
    City
    Shanghai
    State
    CN-NOTA
    Postal Code
    201619
    Country
    CN
    Correspondent
    Li Ning

    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
    Ureteroscope And Accessories, Flexible/Rigid FGB

    Proprietary Names

    Single-use Video Ureterorenoscope (Model: SVU-220US)

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device