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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 (199)

Page 1 of 4

Device	Model / Reference	Registries	Class	Status
Siui	Apogee 1U	FDA UDI	Class II	Active
Siui	CTS-485	FDA UDI	Class II	Active
Siui	CTS-900	FDA UDI	Class II	Active
Siui	SR-2300S	FDA UDI	Class II	Active
Siui	CTS-7700 Plus	FDA UDI	Class II	Active
Siui	SR-2100S	FDA UDI	Class II	Active
Siui	Readius C3	FDA UDI	Class II	Active
Siui	Readius C5	FDA UDI	Class II	Active
Siui	CTS-8800 Plus	FDA UDI	Class II	Active
Siui	CTS-415	FDA UDI	Class II	Active
Siui	SR-2100	FDA UDI	Class II	Active
Siui	CTS-310B	FDA UDI	Class II	Active
Siui	C3L60B	FDA UDI	Class II	Active
Siui	Apogee 5G	FDA UDI	Class II	Active
Siui	SR-1100S	FDA UDI	Class II	Active
Siui	Readius L8	FDA UDI	Class II	Active
Siui	ECBP-2	FDA UDI	Class II	Active
Siui	Apogee 1000Exp	FDA UDI	Class II	Active
Siui	Apogee 1000B/W	FDA UDI	Class II	Active
Siui	Readius P5	FDA UDI	Class II	Active
Siui	Apogee 1T	FDA UDI	Class II	Active
Siui	SR-2300T	FDA UDI	Class II	Active
Siui	C3	FDA UDI	Class II	Active
Siui	Readius P3	FDA UDI	Class II	Active
Siui	Apogee 1G	FDA UDI	Class II	Active
Siui	Apogee 2100 Plus	FDA UDI	Class II	Active
Siui	Apogee 8U	FDA UDI	Class II	Active
Siui	Readius L5	FDA UDI	Class II	Active
Siui	Readius L10	FDA UDI	Class II	Active
Siui	CTS-3300	FDA UDI	Class II	Active
Siui	L8	FDA UDI	Class II	Active
Siui	SR-1000S	FDA UDI	Class II	Active
Siui	Readius V5	FDA UDI	Class II	Active
Siui	Apogee 5T	FDA UDI	Class II	Active
Siui	L7L38B	FDA UDI	Class II	Active
Siui	P3	FDA UDI	Class II	Active
Siui	C6	FDA UDI	Class II	Active
Siui	P3F14G	FDA UDI	Class II	Active
Digital Color Doppler Ultrasound Imaging Scanner	A20	EUDAMED	Class IIa	Active
Portable DR Imaging System	SR-2300Pro	EUDAMED	Class IIb	Active
Multi-frequency Linear-array Ultrasound Probe	L7L38G	EUDAMEDFDA UDI	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	Apogee 3500	EUDAMEDFDA UDI	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	Apogee U3	EUDAMEDFDA UDI	Class IIa	Active
Multi-frequency Linear-array Ultrasound Probe	L5I50	EUDAMED	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	Apogee 6300Pro	EUDAMED	Class IIa	Active
Multi-frequency Linear-array Ultrasound Probe	L8LN	EUDAMEDFDA UDI	Class IIa	Active
Multi-frequency Phased-array Ultrasound Probe	P3F14C	EUDAMEDFDA UDI	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	Apogee 2300Pro	EUDAMED	Class IIa	Active
Digital Color Doppler Ultrasound Imaging Scanner	Readius V6	EUDAMEDFDA UDI	Class IIa	Active
Multi-frequency Convex-array Ultrasound Probe	C3LN	EUDAMEDFDA UDI	Class IIa	Active

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Shanghai International Holding Corp. GmbH(Europe) DE

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