BEUDAMED
    FDA Registration Active 🇨🇳 China

    Apogee 5500

    Reg #: 9615439 · FEI: 3003861317 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD.
    Registration Number
    9615439
    FEI Number
    3003861317
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    77 JINSHA RD.
    City
    SHANTOU Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K160853

    Owner / Operator

    Firm Name
    SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD.
    Operator Number
    9011618
    Address
    77 JINSHA RD.
    City
    SHANTOU
    State
    Guangdong
    Postal Code
    515041
    Country
    CN
    Correspondent
    Guang Chen

    Products

    Device Name Product Code
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX

    Proprietary Names

    Apogee 5500 Apogee 5800 Apogee 5300 Apogee 5T Apogee 5G Apogee 8U

    Establishment Types

    Manufacture Medical Device