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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
—

Catalogue (199)

Page 4 of 4
DeviceModel / ReferenceRegistriesClassStatus
Digital Color Doppler Ultrasound Imaging Scanner A22Exp
EUDAMED
Class IIaActive
Multi-frequency 4D Ultrasound Probe 4DL40G
EUDAMEDFDA UDI
Class IIaActive
Digital Color Doppler Ultrasound Imaging Scanner Apogee C3
EUDAMEDFDA UDI
Class IIaActive
Intelligent Breast Ultrasound Scanner IBUS 30G
EUDAMED
Class IIaActive
Portable DR Imaging System SR-200Pro
EUDAMED
Class IIbActive
Digital Color Doppler Ultrasound Imaging Scanner Apogee 3600Pro
EUDAMED
Class IIaActive
Multi-frequency Phased-array Ultrasound Probe P3FC
EUDAMEDFDA UDI
Class IIaActive
Multi-frequency Phased-array Ultrasound Probe P5FC
EUDAMEDFDA UDI
Class IIaActive
Multi-frequency Convex-array Ultrasound Probe C6LN
EUDAMEDFDA UDI
Class IIaActive
Multi-frequency Endocavity Biplane Ultrasound Probe ECBN
EUDAMEDFDA UDI
Class IIaActive
Intelligent Breast Ultrasound Scanner IBUS 60
EUDAMED
Class IIaActive
Multi-frequency Endocavitary Ultrasound Probe U5L50G
EUDAMED
Class IIaActive
Portable DR Imaging System SR-100
EUDAMED
Class IIbActive
Portable X-ray unit SR-8100
EUDAMEDFDA UDI
Class IIbActive
Digital Color Doppler Ultrasound Imaging Scanner A22Lite
EUDAMED
Class IIaActive
Portable X-ray unit SR-8000
EUDAMEDFDA UDI
Class IIbActive
Multi-frequency Endocavitary Ultrasound Probe U5L50C
EUDAMED
Class IIaActive
Portable X-ray unit SR-8210
EUDAMEDFDA UDI
Class IIbActive
Multi-frequency Linear-array Ultrasound Probe L10LF
EUDAMED
Class IIaActive
Multi-frequency Linear-array Ultrasound Probe L8L38C
EUDAMEDFDA UDI
Class IIaActive
Portable X-ray unit SR-8000S
EUDAMEDFDA UDI
Class IIbActive
Multi-frequency Linear-array Ultrasound Probe L7L50G
EUDAMED
Class IIaActive
Portable DR Imaging System SR-200
EUDAMED
Class IIbActive
Multi-frequency 4D Ultrasound Probe 4DL40K
EUDAMED
Class IIaActive
Digital Color Doppler Ultrasound Imaging Scanner A32
EUDAMED
Class IIaActive
Digital Color Doppler Ultrasound Imaging Scanner Apogee K3
EUDAMEDFDA UDI
Class IIaActive
Multi-frequency Endocavitary Ultrasound Probe C6LF
EUDAMEDFDA UDI
Class IIaActive
Digital Color Doppler Ultrasound Imaging Scanner Apogee 1000
EUDAMEDFDA UDI
Class IIaActive
Multi-frequency Endocavitary Ultrasound Probe V6LC
EUDAMEDFDA UDI
Class IIaActive
Portable X-ray unit SR-9100
EUDAMED
Class IIbActive
Digital Color Doppler Ultrasound Imaging Scanner Apogee 2100Plus
EUDAMED
Class IIaActive
Digital Color Doppler Ultrasound Imaging Scanner A30Pro
EUDAMED
Class IIaActive
Digital Color Doppler Ultrasound Imaging Scanner Apogee 1100Diamond
EUDAMED
Class IIaActive
Multi-frequency Linear-array Ultrasound Probe L8LF
EUDAMED
Class IIaActive
Digital Color Doppler Ultrasound Imaging Scanner Apogee 5500
EUDAMEDFDA UDI
Class IIaActive
Medical Trolley CR-20
EUDAMED
Class IActive
Digital Color Doppler Ultrasound Imaging Scanner Apogee 6200Pro
EUDAMED
Class IIaActive
Portable DR Imaging System SR-300
EUDAMED
Class IIbActive
Multi-frequency Convex-array Ultrasound Probe C3L60G
EUDAMEDFDA UDI
Class IIaActive
Digital Color Doppler Ultrasound Imaging Scanner Readius P8
EUDAMEDFDA UDI
Class IIaActive
Digital Color Doppler Ultrasound Imaging Scanner Apogee 2100
EUDAMEDFDA UDI
Class IIaActive
Multi-frequency Linear-array Ultrasound Probe L8L38K
EUDAMED
Class IIaActive
Multi-frequency 4D Ultrasound Probe C5LF
EUDAMEDFDA UDI
Class IIaActive
Digital Color Doppler Ultrasound Imaging Scanner Apogee 6900
EUDAMED
Class IIaActive
Digital Color Doppler Ultrasound Imaging Scanner A32Exp
EUDAMED
Class IIaActive
Digital Color Doppler Ultrasound Imaging Scanner Apogee 6800Pro
EUDAMED
Class IIaActive
Portable DR Imaging System SR-1100Pro
EUDAMED
Class IIbActive
Multi-frequency Convex-array Ultrasound Probe C3I40
EUDAMEDFDA UDI
Class IIaActive
Portable DR Imaging System SR-300Pro
EUDAMED
Class IIbActive
Multi-frequency Convex-array Ultrasound Probe C3L40A
EUDAMED
Class IIaActive

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