Shantou Institute OF Ultrasonic Instruments Co., Ltd.
Manufacturer and brand owner in Shantou, Guangdong, China. 8 device types, 5 products catalogued, 3 clearances.
Shantou Institute OF Ultrasonic Instruments Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers System, X-Ray, Mobile, Fluid Jet Removal System and 6 other device types. 5 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2007.
8device types registered with the FDA
5products catalogued under its own name
3510(k) clearances
Registration
| Registered name | SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 9615439 |
| FEI number | 3003861317 |
| DUNS | 654090299 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 汕头市超声仪器研究所股份有限公司 |
|---|---|
| Unified social credit code | 91440500455942803T |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shantou |
|---|---|
| Province | Guangdong |
| Address | 77 JINSHA RD. |
| Postal code | 515041 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | Class 1 | CR Series Trolley, CR Series, CR Series Medical Trolley, CR Series Cart | 2019 | 34 |
| Fluid Jet Removal System | Class 2 | HYDROS TRUS Probe | 2024 | 1 |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | Class 2 | SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System, SR-1100 Portable DR Imaging System, SR-1100S Portable DR Imaging System, SR-2300S Portable DR Imaging System, SR-2100 Portable DR Imaging System and 3 more | 2020 | 13 |
| System, Image Processing, Radiological | Class 2 | SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System, SR-1100 Portable DR Imaging System, SR-1100S Portable DR Imaging System, SR-2300S Portable DR Imaging System, SR-2100 Portable DR Imaging System and 3 more | 2020 | 16 |
| System, Imaging, Pulsed Doppler, Ultrasonic | Class 2 | Apogee 1200, Apogee 3800, CTS-8800, Readius P5, Readius C5, Readius V5 and 53 more | 2007 | 22 |
| System, Imaging, Pulsed Echo, Ultrasonic | Class 2 | Apogee 1200, Apogee 3800, CTS-8800, Readius P5, Readius C5, Readius V5 and 56 more | 2007 | 37 |
| System, X-Ray, Mobile | Class 2 | SR-8100S, SR-8100 Portable X-ray Unit, SR-8000S, SR-8000, SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System and 11 more | 2020 | 5 |
| Transducer, Ultrasonic, Diagnostic | Class 2 | Apogee 1200, Apogee 3800, CTS-8800, Readius P5, Readius C5, Readius V5 and 57 more | 2007 | 44 |
Own-Brand Listings
Clearances
3 clearances name Shantou Institute OF Ultrasonic Instruments Co., Ltd. as applicant. 16 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K253058 | 2026-06-18 | IZL | Traditional | This company |
| K243178 | 2025-03-31 | IYN | Traditional | This company |
| K243132 | 2024-12-10 | IYN | Traditional | This company |
| K210317 | 2021-08-19 | IYN | Traditional | Shantou Institute of Ultrasonic Instruments (Siui |
| K210318 | 2021-08-18 | IYN | Traditional | Shantou Institute of Ultrasonic Instruments (Siui |
| K202350 | 2021-01-06 | IZL | Traditional | Shantou Institute of Ultrasonic Instruments (Siui |
| K202353 | 2020-12-23 | IZL | Traditional | Shantou Institute of Ultrasonic Instruments (Siui |
| K200637 | 2020-07-09 | IZL | Traditional | Shantou Institute of Ultrasonic Instruments (Siui |
| K200976 | 2020-06-10 | IZL | Traditional | Shantou Institute of Ultrasonic Instruments (Siui |
| K173000 | 2017-12-07 | IYN | Traditional | Shantou Institute of Ultrasonic Instruments (Siui |
| K160853 | 2016-06-27 | IYN | Traditional | Shantou Institute of Ultrasonic Instruments (Siui |
| K113613 | 2012-06-15 | IYN | Traditional | Shantou Institute of Ultrasonic Instuments |
| K110841 | 2011-04-15 | IYN | Special | Shantou Institute of Ultrasonic Instruments (Siui |
| K102023 | 2010-10-19 | IYN | Traditional | Shantou Institute of Ultrasonic Instruments (Siui |
| K101008 | 2010-06-08 | ITX | Traditional | Shantou Institute of Ultrasonic Instruments (Siui |
| K092907 | 2010-03-05 | IYN | Traditional | Shantou Institute of Ultrasonic Instuments |
| K081110 | 2008-05-16 | IYO | Special | Shantou Institute of Ultrasonic Instuments |
| K070982 | 2007-05-02 | IYO | Traditional | Shantou Institute of Ultrasonic Instuments |
| K061488 | 2006-06-30 | IYN | Special | Shantou Institute of Ultrasonic Instruments (Siui |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.