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SCIVITA MEDICAL TECHNOLOGY CO., LTD.

China·CN-MF-000010305

Last updated September 17, 2026

Information

Country: China
Address: No.2, Qingqiu Street, Suzhou Industrial Park, Suzhou, Jiangsu Prov.,, China
Website: www.scivitamedical.com/index.html
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +86-512-81877788
PRRC Contact: Ruqin Wu
EUDAMED SRN: CN-MF-000010305
FDA FEI Number: 3020746799
DUNS Number: —

Catalogue (172)

Page 1 of 4

Device	Model / Reference	Registries	Class	Status
Single-use Flexible Ureteroscope	SUV-2A-P	EUDAMED	Class IIa	Active
4K UHD Laparoscope	4K1030R	EUDAMEDFDA UDI	Class IIa	Active
4K UHD Laparoscope	4K5545	EUDAMEDFDA UDI	Class IIa	Active
Single-use Ureteral Access Sheath	UB-1240	EUDAMED	Class IIa	Active
Single-use Video Transforaminal Endoscope	SSV-5823L	EUDAMED	Class IIa	Active
4K UHD Laparoscope	4K5545LR	EUDAMEDFDA UDI	Class IIa	Active
Single-use Ureteral Access Sheath	UB-1045	EUDAMED	Class IIa	Active
Single-use Ureteral Access Sheath	UB-1135	EUDAMED	Class IIa	Active
4K UHD Laparoscope	4K1045R	EUDAMEDFDA UDI	Class IIa	Active
Single-use Hystero Videoscope	SHV-6800	EUDAMED	Class IIa	Active
Single-use Ureteral Access Sheath	UA-1235	EUDAMED	Class IIa	Active
Single-use Hystero Videoscope	SHV-B1	EUDAMED	Class IIa	Active
Single-use Video Transforaminal Endoscope	SSV-7315	EUDAMED	Class IIa	Active
Single-use Extraction Baskets	EBF-2519SG	EUDAMED	Class IIa	Active
Single-use Extraction Baskets	EBF-2020DG	EUDAMED	Class IIa	Active
Single-use Ureteral Access Sheath	UB-1040	EUDAMED	Class IIa	Active
3D Visualization System	3DVS-S100C	EUDAMEDFDA UDI	Class I	Active
4K UHD Camera System	EL-4K81/82C	EUDAMED	Class I	Active
Single-use Hystero Videoscope	SHV-B2	EUDAMED	Class IIa	Active
4KINSIGHT UHD Fluorescence Imaging System	4KIR07	EUDAMEDFDA UDI	Class I	Active
Single-use Ureteral Access Sheath	UA-1125	EUDAMED	Class IIa	Active
4K UHD Laparoscope	4K1000	EUDAMEDFDA UDI	Class IIa	Active
Single-use Choledocho Videoscope	SCV-BA1	EUDAMED	Class IIa	Active
Single-use Biopsy Forceps	BFTW-2311	EUDAMEDFDA UDI	Class IIa	Active
4K UHD Camera System	ES-CS4K200/100C	EUDAMEDFDA UDI	Class I	Active
3D Visualization System	3DVS-S100A	EUDAMEDFDA UDI	Class I	Active
Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))	K250210	FDA 510(k)	Class II	Active
Scivita 4KINSIGHT ICG Imaging System	K221252	FDA 510(k)	Class II	Active
Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)	K243708	EUDAMEDFDA 510(k)	Class II	Active
Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D)	K251338	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Broncho Videoscope System	K231521	FDA 510(k)	Class II	Active
Broncho Videoscope System	K210379	FDA 510(k)	Class II	Active
3D Visualization System	3DVS-S100B	EUDAMEDFDA UDI	Class I	Active
4K UHD Laparoscope	4K1000L	EUDAMEDFDA UDI	Class IIa	Active
Single-use Hystero Videoscope	SHV-4830LN	EUDAMED	Class IIa	Active
Single-use Flexible Ureteroscope	SUV-3C-B	EUDAMED	Class IIa	Active
4K UHD Sinuscope	4K4000R	EUDAMED	Class I	Active
Full HD Endoscopic Image Processor	HDVS-S200C	EUDAMEDFDA UDI	Class I	Active
Single-use Ureteral Access Sheath	UB-1245	EUDAMED	Class IIa	Active
Single-use Broncho Videoscope	SBV-1C-B	EUDAMEDFDA UDI	Class IIa	Active
4K UHD Laparoscope	4K5500	EUDAMEDFDA UDI	Class IIa	Active
LED Light Source	ES-LS100D	EUDAMED	Class I	Active
4K UHD Laparoscope	4K1045L	EUDAMEDFDA UDI	Class IIa	Active
Single-use Extraction Baskets	EBF-1506CG	EUDAMED	Class IIa	Active
Stone Collection Bottle	NPA-180	EUDAMED	Class I	Active
4K UHD Laparoscope	4K5500L	EUDAMEDFDA UDI	Class IIa	Active
4K UHD Laparoscope	4K1045	EUDAMEDFDA UDI	Class IIa	Active
Full HD Visualization Endoscopic Image Processor	HDVS-S300A	EUDAMEDFDA UDI	Class I	Active
Single-use Extraction Baskets	EBF-2029SG	EUDAMED	Class IIa	Active
4K UHD Laparoscope	4K5530R	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

Shanghai International Holding Corp. GmbH(Europe) DE

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Scivita Medical Technology Co., Ltd. US