BEUDAMED
    FDA Registration Active 🇨🇳 China

    Apogee 6300

    Reg #: 9615439 · FEI: 3003861317 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    4
    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
    K210318

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

    Proprietary Names

    Apogee 6300 Apogee 6500 Apogee 6200 Apogee 6500 with ECBP-5 transducer

    Establishment Types

    Manufacture Medical Device