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Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)

China·CN-MF-000010834

Last updated May 23, 2026

What Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) makes

Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) manufactures digital color Doppler ultrasound imaging systems, including the Apogee 5500, Apogee 5300, and Apogee 5800 models.

These devices are listed in the FDA 510(k) registry and are classified as Class II medical devices. The company is based in the US.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What does Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) manufacture?

Siui manufactures digital color Doppler ultrasound imaging systems, including the Apogee 5500, Apogee 5300, and Apogee 5800 models. These are medical imaging devices used for diagnostic purposes.

Where is Siui based?

Siui is based in the United States. The company operates from its headquarters in the US, where it designs and manufactures its ultrasound imaging systems.

Which regulatory registries list Siui's devices?

Siui's devices are listed in the FDA 510(k) registry. This means they have been notified to the FDA and are cleared for market under the 510(k) process, which is for devices deemed substantially equivalent to existing devices.

How are Siui's devices classified?

Siui's ultrasound imaging systems are classified as Class II medical devices. Class II devices are those that require more regulation than Class I but less than Class III, and they typically require special controls to ensure their safety and effectiveness.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
China
Address
#77, Jinsha Road, Shantou, Guangdong, China
Website
www.siui.com
LinkedIn
—
Facebook
—
Phone
+86-754-88250151
PRRC Contact
Yanxiong Yu
EUDAMED SRN
CN-MF-000010834
FDA FEI Number
—
DUNS Number
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Catalogue (201)

Page 5 of 5
DeviceModel / ReferenceRegistriesClassStatus
Portable DR Imaging System SR-1100
EUDAMEDFDA UDI
Class IIbActive

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