Manufacturer

Shantou Institute of Ultrasonic Instruments

ChinaLegal entities : Shantou Institute of Ultrasonic Instruments Co., Ltd.

Markets : Germany · United States

Approvals : EU – class IIa, IIb · United States (FDA) – 510(k) : 11 · class I, II · latest in 2026 · see on the FDA website

EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)

Website

4 categories, 36 models including 36 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Ultrasound probes - other	Z11040299	4DL40K, C5LN, 4DL40A, 4DL40G, C5L40C3 refs C3L60K, C3L60A, C3L60C, C3L60G, C3L40C, C3L40G, C6LN, C6LC, C5L40K, C6L15K, C3I40, C3I60F, C3I60, C3I40F, C3L40A, C5I20, C5I40, C5I20G3 refs C3LC C3LN C5LF 18 others C6LF ECBN ECBP ECBP-1 ECBP-5 L10LF, L8LF2 refs L14LC L8L38K, L7L38A, L7L38G, L8L38C, L7I38F, L5I50, L7I50, L7L50G, L8L50C, L8L50K, L10LC, L10LN3 refs L8LC L8LN P3F14K、P3F14C、P5FN、TR2-14、TR5-143 refs P3FC P3FN P5FC U5LC, U5L50G, U5L50C, U5LN3 refs V6L11K, V6LF, V5H11, V6L11A, V6L11G, V6L11C3 refs V6LC V6LN	IIa MDR	EUDAMED record Report an error
Ultrasound scanners - other	Z11040199	A56Exp,A56,A56Pro,A56Lite,A52,A52Pro,A52Lite,A52Exp,A50,A50Pro,A50Lite,A50Exp,A36,A36Pro,A36Lite,A36Exp,A32,A32Pro,A32Lite,A32Exp,A30,A30Pro,A30Lite,A30Exp,A25,A25Pro,A25Lite,A25Exp,A22,A22Pro,A22Lite,A22Exp,A20,A20Pro,A20Lite,A20Exp3 refs Apogee 1000, Apogee 1100Diamond, Apogee 1100Lite, Apogee 1000Neo, Apogee 1000Lite, Apogee 1000Pro, Apogee 1000Ace, CTS-5500, CTS-6600, Apogee 20003 refs Apogee 2300, Apogee 2300Pro, Apogee 2300Ace, Apogee 2100, Apogee 2100Plus, Apogee 1100, Apogee 1100Exp, Apogee 1200, Apogee 1100Neo, CTS-8800, CTS-77003 refs Apogee 3500, Apogee 33002 refs Apogee 3900, Apogee 3900Pro, Apogee 3600Pro, Apogee 5500, Apogee 5300, Apogee 3600, Apogee 3900Ace, Apogee 3600Ace, Apogee 4500, Apogee 48003 refs 6 others Apogee 6500/Apogee 6300/Apogee 6200/Apogee 6500Pro/Apogee 6300Pro/Apogee 6200Pro/Apogee 6500Ace/Apogee 6300Ace/Apogee 6200Ace/Apogee 5500Exp/Apogee 5500Pro/Apogee 5300Neo/Apogee 5300Pro3 refs Apogee 6900, Apogee 6900Pro, Apogee 6900Ace, Apogee 6800, Apogee 6800Pro, Apogee 6800Ace, Apogee 5800, Apogee 5800Exp, Apogee 38003 refs Apogee U5, Apogee U1, Apogee U2, Apogee U3, Apogee C1, Apogee C2, Apogee C3, Apogee C5, Apogee K1, Apogee K2, Apogee K3, Apogee K53 refs CTS-5000, CTS-40002 refs IBUS 60G, IBUS 60, IBUS 30G, IBUS 303 refs Readius L15, Readius P8, Readius V6, Readius C63 refs	IIa MDR	EUDAMED record Report an error
Mobile radiographic units	Z11039016	SR-8230, SR-8230S, SR-8210, SR-8210S, SR-8100, SR-8100S, SR-8000, SR-8000S, SR-9100, SR-9200, SR-93003 refs	IIb MDR	EUDAMED record Report an error
Multifunctional systems for direct digital radiology	Z11031101	SR-2300, SR-2300Pro, SR-2000, SR-200Pro, SR-1100, SR-1100Pro, SR-1000, SR-1000Pro, SR-300, SR-300Pro, SR-200, SR-100, SR-100Pro3 refs	IIb MDR	EUDAMED record Report an error

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