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    FDA Registration Active 🇨🇳 China

    SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD.

    Reg #: 3017944270 · FEI: 3017944270 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    84
    Establishment Types
    2
    Classifications
    7

    Registration Details

    Registration Name
    SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD.
    Registration Number
    3017944270
    FEI Number
    3017944270
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3 Longjiang Road
    City
    Shantou Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K102023

    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

    US Agent

    Business Name
    SIUI International, Inc.
    Contact Name
    Flower Cai
    Address
    1085 12th Ave Nw Ste D7
    City
    Issaquah
    State
    WA
    ZIP
    98027
    Country
    US
    Email
    [email protected]
    Phone
    425 3915346

    Products

    Device Name Product Code
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Cart, Emergency, Cardiopulmonary (Excluding Equipment) BZN
    System, Image Processing, Radiological LLZ
    System, X-Ray, Mobile IZL
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB

    Proprietary Names

    Apogee 3500 Digital Color Doppler Ultrasound imaging System with probe V6L11C Apogee 3500 Digital Color Doppler Ultrasound imaging System CTS-4000 Digital Ultrasound lmaging system Apogee 3300 Digital Color Doppler Ultrasound imaging System CTS-7700 CR Series Medical Trolley CR Series Trolley CR Series Cart CR Series SR-2300S Portable DR Imaging System SR-2300 Portable DR Imaging System SR-2100S Portable DR Imaging System SR-2100 Portable DR Imaging System SR-2300T Portable DR Imaging System CTS-900 Digital Ultrasound Imaging System SR-8230S Portable X-ray Unit SR-8230 Portable X-ray Unit SR-8210 SR-8210S Apogee C2 Apogee U5 Apogee C1 Apogee U2 Apogee U3 Apogee U1 Apogee K5 Apogee C3 Apogee C5 Apogee K1 Apogee K2 Apogee K3 HYDROS TRUS Probe Apogee 3800 Apogee 5500 Apogee 5300 Apogee 5800 Apogee 8U Apogee 5G Apogee 5T SR-8100 Portable X-ray Unit SR-8000S SR-8000 SR-8100S SR-1000 Portable DR Imaging System SR-1000S Portable DR Imaging System SR-1100 Portable DR Imaging System SR-1100S Portable DR Imaging System Apogee 1200 Apogee 2300 with transducers C3LN, L8LN, C5LN, P3FN, V6LN, ECBN, L10LN, U5LN, C6LN, ECBP-1 Apogee 2100 with transducers C3LN, L8LN, C5LN, P3FN, V6LN, ECBN, L10LN, U5LN, C6LN, ECBP-1 Apogee 2100 Plus with transducers C3LN, L8LN, C5LN, P3FN, V6LN, ECBN, L10LN, U5LN, C6LN, ECBP-1 CTS-8800 Apogee 1000 Apogee 1000Neo Apogee 1000Exp Apogee 1T Apogee 1G Apogee 1000B/W Apogee 1U Apogee 1000Lite Apogee 6300 Apogee 6200 Apogee 6500 Apogee 6500 with ECBP-5 transducer CTS-5500 CTS-6600 CTS-3300 Readius P5 Readius C6 Readius P8 Readius L5 Readius C5 Readius V6 Readius L15 Readius L8 Readius V5 Readius C3 Readius L10 Readius P3 Apogee 1100 CTS-8800 Plus CTS-8800Plus CTS-7700 Plus

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)