BEUDAMED
    FDA Registration Active 🇨🇳 China

    IS4000 da Vinci EndoWrist Instruments

    Reg #: 3015487509 · FEI: 3015487509 · 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. C/O Shanghai HMG Medical Supply Chain Service Co.,Ltd.
    Registration Number
    3015487509
    FEI Number
    3015487509
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Room 301/302 of 3rd Floor, Building 6, No.77 Fu Te West 3 Rd., China(Shanghai) Pilot Free Trade Zone
    City
    Shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K150284

    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
    Correspondent
    Tong Wang

    Products

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

    Proprietary Names

    IS4000 da Vinci EndoWrist Instruments

    Establishment Types

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