Manufacturer

Sonoscape

ChinaLegal entities : SONOSCAPE MEDICAL CORP.

Markets : Italy · Netherlands · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 48 · class II · latest in 2026 · see on the FDA website

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

ra@sonoscape.net

34 categories, 137 models including 137 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
Multidisciplinary ultrasound scanners (internal and cardiology, etc.)	Z11040104	Autra 55 Autra RS E30S P10 Exp2 refs Endo 80 Marvo Senior Fenix 70i S90 Exp2 refs M11 P12 Elite 10 others P10 Plus P20 P15 Elite P20 Elite3 refs P22S P602 refs P27 P50 Exp P60 Exp S-Light S60 Expert S-Maso S50 Exp S50 Elite S60 Exp2 refs S60N S702 refs U6 U8 Exp	IIa MDR	EUDAMED record Report an error
Video colonoscopes	Z12020606	EC-2200 EC-330T EC-430 EC-500 EC-550, EC-550T, EC-550L, EC-550L/T 8 others EC-550Z EC-560R EC-650 EC-650Z EC-P550S EC-P560 EC-X20 EC-X20R	IIa MDR	EUDAMED record Report an error
Light sources for endoscopy and minimally invasive surgery	Z12020402	HDL-35E HDL-500X SL-ED10 SL-ED100 SL-ED40 7 others SL-EL200 SL-EL40 VLS-50T, VLS-50D VLS-51T, VLS-51D2 refs VLS-55Q, VLS-55T VLS-65 VLS-65Elite VLS-65Pro	I, IIa MDR	EUDAMED record Report an error
Integrated systems for the acquisition and management of endoscopic and minimally invasive surgery images	Z12020401	HD-320Plus HD-350 HD-330Plus HD-500 HD-400 HD-610 HD-650 SV-M2K30 6 others SV-M4K100Exp SV-M4K120 SV-M4K200Ad SV-M4K200Cu SV-M4K30 SV-M4K40 X-2200 X-2300 X-2600	I, IIa MDR	EUDAMED record Report an error
Video gastroscopes	Z12020511	EG-2200 EG-330 EG-430 EG-500 EG-550, EG-550L 5 others EG-550Z EG-650 EG-650Z EG-P550N EG-X20	IIa MDR	EUDAMED record Report an error
Portable ultrasound scanners	Z11040103	E1 E53 refs E10 X11 Exp2 refs M12 S12 Exp S2 Exp S8 Exp S9 Exp 2 others X1 X3 X52 refs	IIa MDR	EUDAMED record Report an error
Surgical cameras	Z12020405	10-020-213 10-020-413 10-020-414 10-100-201 10-100-401 1 other 10.120.402 10.121.401	I MDR	EUDAMED record Report an error
Various instruments for endoscopy and mini-invasive surgery - consumables	Z12029085	11.100.318 11.100.363 11.101.318 GT-32S PWC-2 1 other PWT-75	I, IIa, IIb MDR	EUDAMED record Report an error
Video bronchoscopes	Z12020802	EB-500 EB-5H20 EB-6P17 EB-UC5 EB-UC5S 1 other EB-X20	IIa MDR	EUDAMED record Report an error
Cardiology ultrasound scanners	Z11040102	V10 V20 V20i V20p	IIa MDR	EUDAMED record Report an error
Echo-gastroscopes	Z12020503	EG-UC5T EG-UC6T-U EG-UC7T EG-UR5	IIa MDR	EUDAMED record Report an error
Two-dimensional linear-array transcutaneous ultrasound probes	Z110402010101	10I2 12L-A3 refs 18L-A3 refs L2-93 refs LAP73 refs	IIa MDR	EUDAMED record Report an error
Curvilinear transcutaneous two-dimensional ultrasound probes (convex-array)	Z110402010201	3C-A3 refs 6CI-A C2-93 refs C611 C6132 refs	IIa MDR	EUDAMED record Report an error
Endocavitary ultrasound probes, two-dimensional	Z1104020201	6V1 6V33 refs BCC9-52 refs BCL10-53 refs	IIa MDR	EUDAMED record Report an error
Laparoscopes	Z12029009	25-230-100 4K.205.100 4KIR.305.103 4K.205.500 4K.205.503	IIa MDR	EUDAMED record Report an error
Transcutaneous ultrasound sector probes (phased array), two-dimensional	Z110402010301	2P13 refs 5P1 7P-A3 refs 8P13 refs	IIa MDR	EUDAMED record Report an error
Upper gastrointestinal tract endoscopy instruments - consumables	Z12020585	BL-20UC BL-20UR CAP-D13D CAP-Z12	I MDR	EUDAMED record Report an error
Video nasopharyngo/laryngoscopes	Z12021006	ENL-110 ENL-110S ENL-110T	IIa MDR	EUDAMED record Report an error
Gas inflators	Z12029008	SF-H400 SF-H500 SF-N400 SF-N500	IIb MDR	EUDAMED record Report an error
Internal ultrasound scanners	Z11040101	EU-102 refs EU-25p	IIa MDR	EUDAMED record Report an error
Ultrasound probes - other	Z11040299	CWD2.02 refs CWD5.02 refs	IIa MDR	EUDAMED record Report an error
Ureterorenoscopes	Z12020713	EUC-110S EUD.100S	IIa MDR	EUDAMED record Report an error
Various instruments for endoscopy and mini-invasive surgery - other	Z12029099	SCP-1 SFP-1	IIa MDR	EUDAMED record Report an error
Curvilinear transcutaneous multidimensional ultrasound probes (convex-array)	Z110402010202	SonoScape VC6-23 refs	IIa MDR	EUDAMED record Report an error
Cystoscopes	Z12020701	ECY-110 ECY-X20	IIa MDR	EUDAMED record Report an error
Endocavitary ultrasound probes, multidimensional	Z1104020202	VE3-10 VE9-53 refs	IIa MDR	EUDAMED record Report an error
Pulmonary endoscopic instruments - hardware accessories	Z12020880	CEB-G01 CEB-U012 refs	I MDR	EUDAMED record Report an error
Transesophageal ultrasound probes, two-dimensional	Z1104020301	MPTEE2 refs	IIa MDR	EUDAMED record Report an error
Upper gastrointestinal tract endoscopy instruments - hardware accessories	Z12020580	CEG-U01	I MDR	EUDAMED record Report an error
Various instruments for endoscopy and mini-invasive surgery - medical device software	Z12029092	SIP-E20	I MDR	EUDAMED record Report an error
Video choledocoscopes	Z12020507	ECH-110	IIa MDR	EUDAMED record Report an error
Video duodenoscopes	Z12020508	ED-5GT	IIa MDR	EUDAMED record Report an error
Video laparoscopes	Z12029016	3D.103.400	IIa MDR	EUDAMED record Report an error
Video processors	Z12020406	HD-500plus HD-550	I MDR	EUDAMED record Report an error

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