BEUDAMED
    FDA Registration Active 🇨🇳 China

    Single use flexible video cystoscope, PC200-S, PC200-R, PC200-AS, PC200-AR

    Reg #: 3013687468 · FEI: 3013687468 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ZHUHAI PUSEN MEDICAL TECHNOLOGY CO, LTD
    Registration Number
    3013687468
    FEI Number
    3013687468
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1F and 5/F, Building 1 and 3, No 33, Keji San Road, High-tech Zone, Tangjiawan Town
    City
    Zhuhai Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K223741

    Owner / Operator

    Firm Name
    Zhuhai Pusen Medical Technology Co., Ltd.
    Operator Number
    10055280
    Address
    5/F, Building 1, No 33, Keji San Road, High-tech Zone, Tangjiawan Town
    City
    Zhuhai
    State
    Guangdong
    Postal Code
    519085
    Country
    CN
    Correspondent
    Changshen Wang

    Products

    Device Name Product Code
    Cystoscope And Accessories, Flexible/Rigid FAJ
    Choledochoscope And Accessories, Flexible/Rigid FBN

    Proprietary Names

    Single use flexible video cystoscope, PC200-S, PC200-R, PC200-AS, PC200-AR medical video endoscope image processor, Eview, PV300 Single use flexible video choledochoscope, PCH100-S, PCH111-S

    Establishment Types

    Manufacture Medical Device