BEUDAMED
    FDA Registration Active 🇨🇳 China

    da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments

    Reg #: 3031605757 · FEI: 3031605757 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    INTUITIVE SURGICAL-FOSUN MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD.
    Registration Number
    3031605757
    FEI Number
    3031605757
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3F of Building 1, 1-2F and 3F room P3001 of Building 5, No.1389 Landian Road, Pudong New District
    City
    Shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K214095

    Owner / Operator

    Firm Name
    Intuitive Surgical-Fosun Medical Technology (Shanghai) Co.,
    Operator Number
    10075632
    Address
    1-2F, BLD1, No.168&178 Banxia Road, Pudong New District
    City
    Shanghai
    State
    CN-SH
    Postal Code
    201318
    Country
    CN

    Products

    Device Name Product Code
    System, Surgical, Computer Controlled Instrument NAY
    Laparoscope, General & Plastic Surgery GCJ

    Proprietary Names

    da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments

    Establishment Types

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