BEUDAMED
    FDA Registration Active 🇨🇳 China

    SureForm 45, SureForm 45 Reloads

    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
    K183224

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

    Proprietary Names

    SureForm 45, SureForm 45 Reloads

    Establishment Types

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