BEUDAMED
    FDA Registration Active 🇨🇳 China

    Single-use Biliary Pancreaticobiliary Scope CL-A, CL-B; Image Processor HUV-02

    Reg #: 3012797688 · FEI: 3012797688 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD
    Registration Number
    3012797688
    FEI Number
    3012797688
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    401, 501, Building 4, Haizhi Technology Park, Fortis, No. 17, Bulan Road,, Xialilang Community, Nanwan Street, Longgang District,
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K241444

    Owner / Operator

    Firm Name
    Shenzhen HugeMed Medical Technical Development Co., Ltd
    Operator Number
    10052108
    Address
    401, 501, Building 4, Haizhi Technology Park, Fortis, No.17, Bulan Road,, Xialilang Community, Nanwan Street, Longgang District,
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518112
    Country
    CN
    Correspondent
    Cathy Shi

    US Agent

    Business Name
    Performance International, Inc.
    Contact Name
    Dennis Xu
    Address
    4004 Pepperton Dr.
    City
    Raleigh
    State
    NC
    ZIP
    27606
    Country
    US
    Email
    [email protected]
    Phone
    919 8590478

    Products

    Device Name Product Code
    Camera, Surgical And Accessories KQM
    Choledochoscope And Accessories, Flexible/Rigid FBN
    Led Light Source NTN
    Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET

    Proprietary Names

    Single-use Biliary Pancreaticobiliary Scope CL-A, CL-B; Image Processor HUV-02

    Establishment Types

    Manufacture Medical Device