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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: —
Email: [email protected]
Phone: +86-754-88250151
PRRC Contact: Yanxiong Yu
EUDAMED SRN: CN-MF-000010834
FDA FEI Number: —
DUNS Number: —

Catalogue (201)

Page 3 of 5

Device	Model / Reference	Registries	Class	Status
Multi-frequency Phased-array Ultrasound Probe	TR2-14	EUDAMED	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	CTS-8800	EUDAMEDFDA UDI	Class IIa	Active
Medical Trolley	CR-12	EUDAMED	Class I	Active
Digital Color Doppler Ultrasound Imaging Scanner	A30Exp	EUDAMED	Class IIa	Active
Multi-frequency Convex-array Ultrasound Probe	C6LC	EUDAMEDFDA UDI	Class IIa	Active
Portable DR Imaging System	SR-100Pro	EUDAMED	Class IIb	Active
Digital Color Doppler Ultrasound Imaging Scanner	Apogee C2	EUDAMEDFDA UDI	Class IIa	Active
Multi-frequency Phased-array Ultrasound Probe	TR5-14	EUDAMED	Class IIa	Active
Multi-frequency Phased-array Ultrasound Probe	P3FN	EUDAMEDFDA UDI	Class IIa	Active
Multi-frequency Linear-array Ultrasound Probe	L8L50C	EUDAMED	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	Apogee 3900Pro	EUDAMED	Class IIa	Active
Multi-frequency Endocavity Biplane Ultrasound Probe	ECBP	EUDAMEDFDA UDI	Class IIa	Active
Portable DR Imaging System	SR-1000	EUDAMEDFDA UDI	Class IIb	Active
Digital Color Doppler Ultrasound Imaging Scanner	A20Pro	EUDAMED	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	Apogee U5	EUDAMEDFDA UDI	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	CTS-5000	EUDAMED	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	Apogee 5500Exp	EUDAMED	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	Apogee 1000Lite	EUDAMEDFDA UDI	Class IIa	Active
Multi-frequency Endocavitary Ultrasound Probe	V6LN	EUDAMEDFDA UDI	Class IIa	Active
Multi-frequency Linear-array Ultrasound Probe	L8LC	EUDAMEDFDA UDI	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	Readius L15	EUDAMEDFDA UDI	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	Apogee 6300	EUDAMEDFDA UDI	Class IIa	Active
Portable DR Imaging System	SR-2000	EUDAMED	Class IIb	Active
Medical Trolley	CR-15	EUDAMED	Class I	Active
Multi-frequency Convex-array Ultrasound Probe	C6L15K	EUDAMED	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	Readius C6	EUDAMEDFDA UDI	Class IIa	Active
Multi-frequency Linear-array Ultrasound Probe	L10LN	EUDAMEDFDA UDI	Class IIa	Active
Multi-frequency Endocavitary Ultrasound Probe	U5LC	EUDAMEDFDA UDI	Class IIa	Active
Intelligent Breast Ultrasound Scanner	IBUS 30	EUDAMED	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	Apogee U1	EUDAMEDFDA UDI	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	Apogee 3300	EUDAMEDFDA UDI	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	Apogee 1200	EUDAMEDFDA UDI	Class IIa	Active
Multi-frequency Linear-array Ultrasound Probe	L7I50	EUDAMEDFDA UDI	Class IIa	Active
Multi-frequency Phased-array Ultrasound Probe	P3F14K	EUDAMED	Class IIa	Active
Portable X-ray unit	SR-9200	EUDAMED	Class IIb	Active
Digital Color Doppler Ultrasound Imaging Scanner	Apogee 5300	EUDAMEDFDA UDI	Class IIa	Active
Multi-frequency Convex-array Ultrasound Probe	C3L60C	EUDAMEDFDA UDI	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	Apogee 1000Neo	EUDAMEDFDA UDI	Class IIa	Active
Portable X-ray unit	SR-9300	EUDAMED	Class IIb	Active
Multi-frequency Endocavity Biplane Ultrasound Probe	ECBP-5	EUDAMEDFDA UDI	Class IIa	Active
Multi-frequency Endocavitary Ultrasound Probe	V6L11A	EUDAMED	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	Apogee 6500	EUDAMEDFDA UDI	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	CTS-7700	EUDAMEDFDA UDI	Class IIa	Active
Multi-frequency Convex-array Ultrasound Probe	C3LC	EUDAMEDFDA UDI	Class IIa	Active
Portable DR Imaging System	SR-1000Pro	EUDAMED	Class IIb	Active
Multi-frequency Linear-array Ultrasound Probe	L7L38A	EUDAMED	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	Apogee 1100	EUDAMEDFDA UDI	Class IIa	Active
Multi-frequency Endocavitary Ultrasound Probe	V5H11	EUDAMED	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	Apogee 5300Neo	EUDAMED	Class IIa	Active
Multi-frequency Endocavitary Ultrasound Probe	V6LF	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

Shanghai International Holding Corp. GmbH(Europe) DE

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