Manufacturer

Scivitamedical

ChinaLegal entities : Scivita Medical Technology Co., Ltd.

Markets : Austria · Belgium · Germany · Spain · United States

Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 13 · class I, II · latest in 2026 · see on the FDA website

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

Website info@scivitamedical.com

15 categories, 28 models including 28 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
Video processors	Z12020406	3D Visualization System 3DVS-S100A,3DVS-S100B,3DVS-S100C,3DVS-S100D,3DVS-S100E3 refs 4K UHD Camera System EL-4K81/82C, EL-4K82/82C2 refs 4K UHD Camera System ES-CS4K100/100C,ES-CS4K100/200C,ES-CS4K200/200C,ES-CS4K200/100C3 refs 4KINSIGHT UHD Fluorescence Imaging System 4KIR01 4KIR02 4KIR03 4KIR04 4KIR05 4KIR06 4KIR07 4KIR08 4KIR09 4KIR10 4KIR11 4KIR122 refs Endoscopic Image Processor HDVS-S100A、HDVS-S100B、HDVS-S100C、HDVS-S100D、HDVS-S100E3 refs 2 others Full HD Endoscopic Image Processor HDVS-S200A 、HDVS-S200B 、HDVS-S200C、 HDVS-S200D3 refs Full HD Visualization Endoscopic Image Processor HDVS-S300A、 HDVS-S300B、 HDVS-S300C、 HDVS-S300D3 refs	I MDR	EUDAMED record Report an error
Arthroscopes	Z12021101	4K UHD Arthroscope 4K4000,4K4030,4K40703 refs 4K UHD Sinuscope 4K4000、4K4030、4K4070 4K4000R、4K4030R、4K4070R3 refs Single-use Video Arthroscope SAV-4000、SAV-40302 refs Single-use Video Transforaminal Endoscope SSV-5823、SSV-5823L、SSV-6315、SSV-6323、 SSV-6323L、SSV-7023、SSV-7315、SSV-7315L、SSV-7323、SSV-1015、SSV-1015L3 refs	I, IIa MDR	EUDAMED record Report an error
Hysteroscopes	Z12020704	Single-use Hystero Videoscope SHV-4800, SHV-6800, SHV-4830, SHV-4830L, SHV-4830N, SHV-4830LN, SHV-6830, SHV-6830L, SHV-6830N, SHV-6830LN, SHV-5830, SHV-5830L, SHV-5830N, SHV-5830LN3 refs Single-use Hystero Videoscope SHV-B1,SHV-P1,SHV-B2,SHV-P23 refs Single-use Hystero Videoscope SHV-S1，SHV-S22 refs	IIa MDR	EUDAMED record Report an error
Gas inflators	Z12029008	Insufflator SL101 Insufflator SL102	IIa MDR	EUDAMED record Report an error
Light sources for endoscopy and minimally invasive surgery	Z12020402	LED Light Source ES-LS100D,ES-LS110D2 refs Near-infrared LED Light Source LSIR300 LSIR310 LSIR320 LSIR3303 refs	I MDR	EUDAMED record Report an error
Bronchoscopes	Z12020801	Single-use Broncho Videoscope SBV-1A-B, SBV-1A-P,SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P3 refs	IIa MDR	EUDAMED record Report an error
Choledocoscopes	Z12020501	Single-use Choledocho Videoscope SCV-BA1 、SCV-BA2 、SCV-PA1 、SCV-PA23 refs	IIa MDR	EUDAMED record Report an error
Cystoscopes	Z12020701	Single-use Flexible Cystoscope SUV-1D-B, SUV-1D-P, SUV-3D-B, SUV-4D-B3 refs	IIa MDR	EUDAMED record Report an error
Endometrial ablation equipment	Z12080201	Omni Power System PS-100	IIa MDR	EUDAMED record Report an error
Gynaecology and fertility treatment instruments - consumables	Z12080285	Irrigation Tube ITB-100	IIa MDR	EUDAMED record Report an error
Laparoscopes	Z12029009	4K UHD Laparoscope 4K5500(&R),4K5530(&R),4K5545(&R),4K1000(&R),4K1030(&R),4K1045(&R),4K1000L(&LR),4K1030L(&LR),4K1045L(&LR),4K5500L(&LR)，4K5530L(&LR)，4K5545L(&LR)3 refs	IIa MDR	EUDAMED record Report an error
Morcellators	Z12080204	Single-use Resecting Device BHA-4032, BHA-4035, BHA-2932, BHA-2935, BHB-4032, BHB-4035, BHB-2932, BHB-29353 refs	IIa MDR	EUDAMED record Report an error
Uteroscopes	Z12020709	Single-use Flexible Ureteroscope SUV-(1A-B,1A-P,2A-B,2A-P,2B-B,2B-P,2C-B,2C-P,3A-B,3C-B,4A-B,4C-B,1A-BF, 2A-BF, 2B-BF, 2C-BF, 3C-BF, 4C-BF, 1F-BF, 2F-BF), SUVB-(1F-BF , 2F-BF),SUVC-(1F-BF, 2F-BF), SUVG-(1F-BF, 2F-BF),SUVI-1F-BF, SUVE-1F-BF3 refs	IIa MDR	EUDAMED record Report an error
Video choledocoscopes	Z12020507	Single-use Video Cholangioscope SCV-P-01G，SCV-P-02G，SCV-P-03G，SCV-P-04G，SCV-P-05G3 refs	IIa MDR	EUDAMED record Report an error
Walking trolleys	Y120612	Medical Trolley MT-OP3, MT-OP42 refs	I MDR	EUDAMED record Report an error

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