BEUDAMED
    FDA Registration Active 🇨🇳 China

    Apogee U2 Digital Color Doppler Ultrasound Imaging System

    Reg #: 9615439 · FEI: 3003861317 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    12
    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
    K243178

    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
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, Imaging, Pulsed Doppler, Ultrasonic IYN

    Proprietary Names

    Apogee U2 Digital Color Doppler Ultrasound Imaging System Apogee C3 Digital Color Doppler Ultrasound Imaging System Apogee U3 Digital Color Doppler Ultrasound Imaging System Apogee K2 Digital Color Doppler Ultrasound Imaging System Apogee U1 Digital Color Doppler Ultrasound Imaging System Apogee K5 Digital Color Doppler Ultrasound Imaging System Apogee K3 Digital Color Doppler Ultrasound Imaging System Apogee C1 Digital Color Doppler Ultrasound Imaging System Apogee K1 Digital Color Doppler Ultrasound Imaging System Apogee U5 Digital Color Doppler Ultrasound Imaging System Apogee C2 Digital Color Doppler Ultrasound Imaging System Apogee C5 Digital Color Doppler Ultrasound Imaging System

    Establishment Types

    Manufacture Medical Device