BEUDAMED
    FDA Registration Active 🇨🇳 China

    ZHUHAI PUSEN MEDICAL TECHNOLOGY CO, LTD

    Reg #: 3013687468 · FEI: 3013687468 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    19
    Establishment Types
    1
    Classifications
    7

    Registration Details

    Registration Name
    ZHUHAI PUSEN MEDICAL TECHNOLOGY CO, LTD
    Registration Number
    3013687468
    FEI Number
    3013687468
    Status
    Active
    Expiry Year
    2026
    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
    K260521

    Owner / Operator

    Firm Name
    Zhuhai Pusen Medical Technology Co., Ltd.
    Operator Number
    10055280
    Address
    No. 1118, Jinrui Yi Road, High-tech Zone
    City
    Zhuhai
    State
    Guangdong
    Postal Code
    519085
    Country
    CN
    Correspondent
    Changshen Wang

    Products

    Device Name Product Code
    Endoscopic Access Overtube, Gastroenterology-Urology FED
    Laryngoscope, Rigid CCW
    Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt PTS
    Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET
    Cystoscope And Accessories, Flexible/Rigid FAJ
    Ureteroscope And Accessories, Flexible/Rigid FGB
    Choledochoscope And Accessories, Flexible/Rigid FBN

    Proprietary Names

    ClearEVAC Ureteral Aspirating Access Sheath US-100-1040,US-100-1050,US-100-1240,US-100-1250 single use video laryngoscope BL100 Single use grasping forceps; Single use biopsy forceps; PGA; PGB medical video endoscope image processor Eview PV210, PV220 HD Medical Video Endoscope Image Processor, PV300 Single use flexible video cystoscope, PC200-AR, PC200-AS, PC200-R, PC200-S PU630A-S, PU630A-R, PU632A-S, PU632A-R Single Use Video Ureteroscope Direct In-Scope Suction PU631A-S, PU631A-R, PU633A-S, PU633A-R Single Use Flexible Video Ureteroscope PU400A-S, PU400A-R, PU411A-S, PU411A-R Single Use Video Ureteroscope Direct In-Scope Suction PU3033AH-S, PU3033AH-R, PU3033H-S, PU3033H-R Single Use Video Ureteroscope Direct In-Scope Suction medical video endoscope image processor, Eview, PV300 Single use flexible video cystoscope, PC200-S, PC200-R, PC200-AS, PC200-AR Single use flexible video choledochoscope, PCH100-S, PCH111-S Single use flexible video ureteroscope, PU3033A-S, PU3033A-R, PU3022A, PU3022 medical video endoscope image processor, Eview, UTV100

    Establishment Types

    Manufacture Medical Device