BEUDAMED
    FDA Registration Active 🇨🇳 China

    SureForm 45 Curved Tip, SureForm 45 Gray Reload

    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
    K190999

    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
    Staple, Implantable GDW
    System, Surgical, Computer Controlled Instrument NAY

    Proprietary Names

    SureForm 45 Curved Tip, SureForm 45 Gray Reload

    Establishment Types

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