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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 2 of 5

Device	Model / Reference	Registries	Class	Status
Multi-frequency Endocavity Biplane Ultrasound Probe	ECBP-1	EUDAMEDFDA UDI	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	Apogee K2	EUDAMEDFDA UDI	Class IIa	Active
Multi-frequency Convex-array Ultrasound Probe	C3I60F	EUDAMED	Class IIa	Active
Portable DR Imaging System	SR-2300	EUDAMEDFDA UDI	Class IIb	Active
Digital Color Doppler Ultrasound Imaging Scanner	Apogee 6200	EUDAMEDFDA UDI	Class IIa	Active
Portable X-ray unit	SR-8230S	EUDAMEDFDA UDI	Class IIb	Active
Digital Color Doppler Ultrasound Imaging Scanner	Apogee 3800	EUDAMEDFDA UDI	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	Apogee 6800Ace	EUDAMED	Class IIa	Active
Multi-frequency Endocavitary Ultrasound Probe	V6L11K	EUDAMED	Class IIa	Active
Multi-frequency Phased-array Ultrasound Probe	P5FN	EUDAMEDFDA UDI	Class IIa	Active
Medical Trolley	CR-30A	EUDAMEDFDA UDI	Class I	Active
Digital Color Doppler Ultrasound Imaging Scanner	Apogee K5	EUDAMEDFDA UDI	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	A50Pro	EUDAMED	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	Apogee 2300	EUDAMEDFDA UDI	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	Apogee K1	EUDAMEDFDA UDI	Class IIa	Active
Multi-frequency Linear-array Ultrasound Probe	L10LC	EUDAMEDFDA UDI	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	A22	EUDAMED	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	Apogee 3900	EUDAMED	Class IIa	Active
Multi-frequency Convex-array Ultrasound Probe	C3I40F	EUDAMED	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	CTS-5500	EUDAMEDFDA UDI	Class IIa	Active
Multi-frequency 4D Ultrasound Probe	C5L40C	EUDAMEDFDA UDI	Class IIa	Active
Portable X-ray unit	SR-8230	EUDAMEDFDA UDI	Class IIb	Active
Digital Color Doppler Ultrasound Imaging System, Model Apogee 3500, Convex Array Transducer, Model C3l60c	K102023	FDA 510(k)	Class II	Active
Cts-5500/Cts-6600 Ultrasonic Pulsed Echo Imaging System	K061488	FDA 510(k)	Class II	Active
Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler Ultrasound Imaging System (Apogee C2); Digital Color Doppler Ultrasound Imaging System (Apogee C3); Digital Color Doppler Ultrasound Imaging System (Apogee C5); Digital Color Doppler Ultrasound Imaging System (Apogee K1); Digital Color Doppler Ultrasound Imaging System (Apogee K2); Digital Color Doppler Ultrasound Imaging System (Apogee K3); Digital Color Doppler Ultrasound Imaging System (Apogee K5); Di	K243178	FDA 510(k)	Class II	Active
Digital Color Doppler Ultrasound Imagaing System; Convex / Linear Phased Array Transducer	K103144	FDA 510(k)	Class II	Active
Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6)	K243132	FDA 510(k)	Class II	Active
Digital Color Doppler Ultrasound Imaging System, Convex Array Transducer, Linear Array	K101008	FDA 510(k)	Class II	Active
Digital Color Doppler Ultrasound Imaging System, Convex / Linear / Phased Array Transducer	K110841	FDA 510(k)	Class II	Active
Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System	K160853	FDA 510(k)	Class II	Active
Multi-frequency Linear-array Ultrasound Probe	L8L50K	EUDAMED	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	A36Exp	EUDAMED	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	A20Exp	EUDAMED	Class IIa	Active
Portable X-ray unit	SR-8210S	EUDAMEDFDA UDI	Class IIb	Active
Multi-frequency 4D Ultrasound Probe	C5LN	EUDAMEDFDA UDI	Class IIa	Active
Multi-frequency Linear-array Ultrasound Probe	L14LC	EUDAMEDFDA UDI	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	Apogee C5	EUDAMEDFDA UDI	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	Apogee 6500Pro	EUDAMED	Class IIa	Active
Multi-frequency Endocavitary Ultrasound Probe	U5LN	EUDAMEDFDA UDI	Class IIa	Active
Multi-frequency Endocavitary Ultrasound Probe	V6L11C	EUDAMED	Class IIa	Active
Intelligent Breast Ultrasound Scanner	IBUS 60G	EUDAMED	Class IIa	Active
Multi-frequency Linear-array Ultrasound Probe	L7I38F	EUDAMED	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	Apogee U2	EUDAMEDFDA UDI	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	A56Lite	EUDAMED	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	Apogee C1	EUDAMEDFDA UDI	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	CTS-6600	EUDAMEDFDA UDI	Class IIa	Active
Portable X-ray unit	SR-8100S	EUDAMEDFDA UDI	Class IIb	Active
Multi-frequency Convex-array Ultrasound Probe	C5I20G	EUDAMED	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	Apogee 5800	EUDAMEDFDA UDI	Class IIa	Active
Multi-frequency Endocavitary Ultrasound Probe	V6L11G	EUDAMED	Class IIa	Active

Related Companies

Authorised Representatives

Shanghai International Holding Corp. GmbH(Europe) DE

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