Instruments for functional explorations and therapeutic interventionsEndoscopic and minimally invasive surgery instrumentsGenitourinary endoscopy instruments

Ureterorenoscopes

EMDN code Z12020713

31 manufacturers, 65 models including 65 on the market, 4 countries

On the market in Manufacturer country

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Manufacturers registered in Europe (EUDAMED) 31

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

Manufacturer	Country	Registered models	Class	Contact
Blazejewski	Germany	URS. 027.00.1500a2 refs93/42 URS. 027.00.3100a2 refs93/42 URS. 027.00.4250a3 refs93/42 URS. 030.00.1500a2 refs93/42 URS. 030.00.3100a2 refs93/42 11 others URS. 030.00.4250a93/42 URS. 031.00.4250a93/42 URS. 031.06.4250a93/42 URS. 034.00.4250a4 refs93/42 URS. 040.00.15002 refs93/42 URS. 040.00.1500a93/42 URS. 040.00.200093/42 URS. 040.00.310093/42 URS. 040.00.3100a93/42 URS. 040.00.4250a93/42 URS. 044.00.4250a5 refs93/42	IIa 93/42	Website info@blazejewski.de EUDAMED record Report an error
Richard Wolf FDA	Germany	100002011948 refs93/42 1000020124813 refs93/42 100002014364 refs93/42 10000201465	I, IIa MDR, 93/42	info@richard-wolf.com EUDAMED record Report an error
Seesheen EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Seesheen UR-132893/42 Seesheen UR-133193/42 UR-332, UR-3282 refs URD-1、URD-1S、URD-1R、URD-1SR3 refs	IIa MDR, 93/42	Website EUDAMED record Report an error
Gimmi FDA	Germany	URETERO-RENOSCOPE HD2 refs93/42 URETERO-RENOSCOPE HD, THIN2 refs93/42 URETERO-RENOSCOPE HD, ULTRA THIN93/42	IIa 93/42	Website EUDAMED record Report an error
Guangzhou Red Pine Medical Instrument FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	RP-U-C03R9, RP-U-C03S9, RP-U-C03R3, RP-U-C03S3, RP-U-C04R9, RP-U-C04S9, RP-U-C04R3, RP-U-C04S3, RP-U-C06R9, RP-U-C06S9, RP-U-C06R3, RP-U-C06S3, RP-U-C06BR9, RP-U-C06BS9, RP-U-C06BR3, RP-U-C06BS33 refs Single-Use Video Flexible Ureterorenoscope RP-U-C0306F, RP-U-C0307F, RP-U-C0306FS9, RP-U-C0307FS93 refs Single-Use Video Flexible Ureterorenoscope RP-U-C12, RP-U-C0304, RP-U-C0305, RP-U-C12S3, RP-U-C12S9, RP-U-C12R3, RP-U-C0304S3, RP-U-C0304S9, RP-U-C0304R3, RP-U-C0305S3, RP-U-C0305S9, RP-U-C0305R3, RP-U-C12., RP-U-C12K, RP-U-C0305B3 refs	IIa MDR	Website regulation@gzredpine.com EUDAMED record Report an error
Hangzhou Hawk Optical Electronic Instruments FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Rigid Video Ureterorenoscope YDSN-I2 refs SN-I3 refs Urétéroscope souple F6.5 DPG-V3 refs	I, IIa MDR	Website EUDAMED record Report an error
Seegen FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	UV-US100-H,UV-US110-H,UV-US120-H,UV-US130-H,UV-US100X-H,UV-US100D-H, UV-US120-H-3U, UV-US130-H-3U, UV-US100D-H-3U3 refs UV-US100S-H, UV-US110S-H, UV-US100TS-H, UV-US110DS-H, UV-US120DS-H, UV-US121S-H, UV-US130S-H, UV-US140S-H, UV-US150S-H3 refs UV-US121-H, UV-US101D-H, UV-US140-H, UV-US140-H-3U, UV-US100T-H, UV-US100T-H-3U, UV-US110T-H, UV-US110T-H-3U, UV-US110D-H, UV-US110D-H-3U, UV-US150-H, UV-US150-H-3U, UV-US120D-H3 refs	IIa MDR	Website EUDAMED record Report an error
Zhuhai Vision Medical Technology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	DUC-M10, DUC-M20, DUC-M30, DUC-N10, DUC-N303 refs Flexible Digital Uretero-Renoscope3 refs SUF25,SUF28, SUF303 refs	IIa MDR	service@vision-medt.com EUDAMED record Report an error
Hunan Reborn Medical Science Technology Development EU representative : MedPath GmbH (Germany)	China	Digital Flexible Ureteroscope Disposable Digital Flexible Ureteroscope3 refs	IIa MDR	EUDAMED record Report an error
Sonoscape FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	EUC-110S EUD.100S	IIa MDR	ra@sonoscape.net EUDAMED record Report an error
Unimicromed EU representative : Wellkang Ltd (Northern Ireland)	China	UNC-UT25A, UNC-UT25B, UNC-UT25C, UNC-UT25D, UNC-UT25E, UNC-UT31A, UNC-UT31B, UNC-UT31C, UNC-UT31D, UNC-UT31E3 refs UNEN-BD50A, UNEN-BD50B, UNEN-BD50C, UNEN-BD50D, UNEN-BD50E3 refs	IIa MDR	Website EUDAMED record Report an error
Alton FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Single-Use Ureteroscope3 refs	IIa MDR	info@alton.com.cn EUDAMED record Report an error
Ambu FDA	Denmark	Ambu® aScope 5 Uretero2 refs	IIa MDR	Website EUDAMED record Report an error
Anhui Happiness Workshop Medical Instruments FDA EU representative : Lotus NL B.V. (Netherlands)	China	Digital Flexible Ureteroscope for Single Use3 refs	IIa MDR	EUDAMED record Report an error
Aohua EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Video Ureterorenoscope VRP-XQ3002 refs	IIa MDR	EUDAMED record Report an error
Besdatatech FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	Single use flexible ureteroscope UR-D1,UR-D2,UR-F1,UR-F2,UR-F3,UR-F4,UR-F5,UR-F6,UR-F8,UR-F93 refs	IIa MDR	support@besdatatech.com EUDAMED record Report an error
Bonreemed FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Disposable electronic ureteroscope URS3006，URS3006S，URS3016，URS3016S	IIa MDR	Website EUDAMED record Report an error
Ezisurg FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	enScope™ Single Use Digital Flexible Ureteroscope3 refs	IIa MDR	Website ra@ezisurg.com EUDAMED record Report an error
Himaging FDA EU representative : Lotus NL B.V. (Netherlands)	China	Single-use Flexible Video Ureterorenoscope DURS1-121P, DURS1-121PR,DURS1-121PS,DURS1-121PRS,DURS1-120P,DURS1-120PR,DURS1-120PS,DURS1-120PRS3 refs	IIa MDR	EUDAMED record Report an error
Huger FDA EU representative : Lotus NL B.V. (Netherlands)	China	SVU-220	IIa MDR	Website EUDAMED record Report an error
Hunan Endovascular Device EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	EU-306711L3 refs	IIa MDR	Sales@hnevd.com EUDAMED record Report an error
Innoview FDA	Germany	Ureterorenoscope3 refs	IIa MDR	Website mail@innoview.info EUDAMED record Report an error
Jiangsu Mole Electronic Technology FDA EU representative : phoenix Medtech GmbH (Germany)	China	Single-Use Uroscope YS-U-32123 refs	IIa MDR	EUDAMED record Report an error
MacroLux Medical Technology FDA EU representative : Wellkang Ltd (Northern Ireland)	China	CoralView U10, U10-B, U10-BR, U20, U20-B, U20-BR3 refs	IIa MDR	EUDAMED record Report an error
Ningbo Xinwell Medical Technology FDA EU representative : Lotus NL B.V. (Netherlands)	China	Single-Use Digital Flexible Ureteroscopes XY-S600-A，XY-S600-B，XY-L600-A，XY-L600-B，XY-S630-A，XY-S630-B，XY-L630-A，XY-L630-B，XY-S650-A，XY-S650-B，XY-L650-A，XY-L650-B3 refs	IIa MDR	EUDAMED record Report an error
Otumed FDA EU representative : MedNet EC-REP GmbH (Germany)	United States	Aptra OTU-100RL, OTU-100RR, OTU-100SL, OTU-100SR, OTU-120R, OTU-120S,3 refs	IIa MDR	sales@otumed.com EUDAMED record Report an error
Pusenmedical FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Clear EVAC PU3022, PU3022A, PU3033A, PU3033AH; PU400A, PU411A; PU500-AS, PU500-AR, PU501-AS, PU501-AR; PU630A-S, PU630A-R, PU631A-S, PU631A-R;3 refs	IIa MDR	Website EUDAMED record Report an error
Shanghai Anqing Medical Instrument FDA EU representative : Emergo Europe B.V. (Netherlands)	China	US31D-12-US, US31D-12-EU and etc.3 refs	IIa MDR	ra_dept@anqing-sh.com EUDAMED record Report an error
Yigaomedical FDA EU representative : TRANSMED GLOBAL CONSULTING, S.L. (Spain)	China	Disposable Digital Flexible Ureteroscope2 refs	IIa MDR	EUDAMED record Report an error
Zhejiang Geyi Medical Instrument FDA EU representative : MedPath GmbH (Germany)	China	GY-UR9.33 refs	IIa MDR	EUDAMED record Report an error
Zsrbiomedical FDA EU representative : Caretechion GmbH (Germany)	China	Single-Use Digital Flexible Ureteroscope ZSR-URS-01、ZSR-URS-02、ZSR-URS-03、ZSR-URS-04	IIa MDR	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

Other manufacturers known in the United States (FDA) 66

Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.

Manufacturer	Country	Brands	FDA clearance
Karl Storz GmbH & Co. KG Present in Europe in other categories	Germany	n.a. Flex-X Flex-X / IMAGE 1 S TIPCAM1 n.a,	K253411 (2025)
MAXIFLEX, LLC	–	SemiFlex Scope	registered
Olympus Medical Systems Corp. Present in Europe in other categories	Japan	URETERO-RENO VIDEOSCOPE URETERO-RENO FIBERSCOPE VISERA 4K UHD XENON LIGHT SOURCE ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE REMOTE CABLE FOR CV-CV LIGHT SOURCE CABLE WITH REMOTE 1.8M	K181451 (2019)
Boston Scientific Corp Present in Europe in other categories	United States	LithoVue StoneSmart™ Connect LithoVue™ Elite LithoVue™ LithoVue System	K261153 (2026)
Olympus Winter & Ibe GmbH Present in Europe in other categories	Germany	Olympus OES ELITE	K200369 (2020)
Hunan Vathin Medical Instrument Co., Ltd. Present in Europe in other categories	China	Single-use Flexible Ureteroscope Digital Video Processor	K250785 (2025)
Dornier Medtech America, Inc. Present in Europe in other categories	United States	Dornier MedTech Dornier Axis II Axis II	registered
Gyrus Acmi, Inc. Present in Europe in other categories	United States	Gyrus ACMI SlimLine Bagley	K233275 (2024)
Ningbo Wise Optomech Technology Corporation Present in Europe in other categories	China	WiScope®	registered
Shenzhen HugeMed Medical Technical Development Co., Ltd. Present in Europe in other categories	China	Single-Use Ureterorenoscope Image Processor	K240374 (2024)
Hunan Endoso Life Technology Co., Ltd Present in Europe in other categories	China	Endoso	K241956 (2025)
AMERICAN MEDICAL ENDOSCOPY, INC.	United States	Strauss Surgical	registered
SCHÖLLY FIBEROPTIC GmbH Present in Europe in other categories	Germany	–	registered
SEPLOU (ZHUHAI) CO.,LTD.	China	SEPLOU	K250049 (2025)
SG ENDOSCOPY PTE. LTD.	Singapore	F88	K243894 (2025)
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. Present in Europe in other categories	China	DeepEye	registered
Auris Health, Inc.	United States	MONARCH™Platform, Urology Monarch® Ureteroscopy Kit MONARCH™ Urology Irrigation Cartridge MONARCH™ Ureteroscope Valve	K213334 (2022)
STRYKER CORPORATION Present in Europe in other categories	United States	Uro/Gyn Accessories Flexvision	registered
BLACK DIAMOND VIDEO, INC.	United States	Uretero1 Vision1	registered
Calyxo, Inc.	United States	CVAC Aspiration System CVAC Image Processor	K261447 (2026)
INNOVATIVE ENDOSCOPY COMPONENTS, L.L.C.	United States	IEC-Innoview GmbH	K062707 (2006)
Scivita Medical Technology Co., Ltd. Present in Europe in other categories	China	4K UHD Camera System Single-use Flexible Ureteroscope	K262552 (2026)
CENTERPOINT SYSTEMS LLC	United States	RenaNav Single-Use Digital Flexible Ureteroscope RenaNav Video Processing Unit	K223097 (2023)
Dyne Medical Group, Inc.	South Korea	URUS URUS System	K240203 (2024)
HOYA CORPORATION	United States	PENTAX	registered
Pentax of America, Inc. Present in Europe in other categories	United States	FIBER URETEROSCOPE	registered
Advanced MedTech Corporate Pte Ltd	Singapore	–	registered
Almikro GmbH & Co. KG	Germany	–	registered
Anhui Happiness Workshop Instruments Co., Ltd.	China	–	K252929 (2026)
BACHER MEDIZINTECHNIK GMBH	Germany	–	registered
Biomerics	United States	–	registered
Boyd Weiler GmbH & Co. KG	Germany	–	registered
BriteMED Technology Inc. Present in Europe in other categories	Taiwan	–	registered
Contra Healthcare Solutions, LLC	United States	–	K243532 (2025)
Cook, Inc.	United States	–	registered
Elmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi	Türkiye	–	K233700 (2024)
Fong's Engineering & Manufacturing Private Limited	Singapore	–	registered
HOYA Corporation PENTAX Division	United States	–	registered
Haager GmbH & Co. KG	Germany	–	registered
Henke-Sass, Wolf GmbH Present in Europe in other categories	United States	–	registered
Ian Jamieson Pty Ltd	Australia	–	registered
Ikegami tsushinki Co., Ltd.	Japan	–	registered
Jabil Inc.	United States	–	registered
KARL STORZ Endoscopy-America, Inc.	United States	–	K212458 (2022)
Karl Storz Endovision, Inc.	United States	–	K232911 (2024)
Kunststoff Helmbrechts AG	Germany	–	registered
MDTGlobal, a.s.	Slovakia	–	registered
MKA MEDIKAL IC VE DIS TICARET SANAYI LIMITED SIRKETI	Türkiye	–	registered
Martech Medical Products, Inc.	United States	–	registered
Merit Medical Systems, Inc. Present in Europe in other categories	United States	–	registered
Nissha Medical Technologies Present in Europe in other categories	United States	–	registered
OSYPKA GmbH	Germany	–	registered
Olympus America, Inc. Present in Europe in other categories	United States	–	K951855 (1995)
Opcom Medical, Inc.	Taiwan	–	K242699 (2025)
PAJUNK GmbH Medizintechnologie	Germany	–	registered
Polimeros Formula de Tecate, SA de CV	Mexico	–	registered
Richard Wolf Medical Instruments Corp.	United States	–	K201897 (2021)
Roen Surgical, Inc.	South Korea	–	K253505 (2026)
Rudolf Medical GmbH + Co. KG	Germany	–	registered
STERIS Corporation Present in Europe in other categories	United States	–	K231878 (2023)
Schoelly Fiberoptic GmbH	Germany	–	registered
Shenzhen Sanping Image Technology Co., Ltd.	China	–	K250917 (2025)
Shern Yeong Precise Optical Co., Ltd.	Taiwan	–	registered
VOMA ECZA DEPOSU MEDIKAL URUNLER SAN. TIC. A.S.	Türkiye	–	registered
Vein360 LLC	United States	–	K260708 (2026)
Viant Medical, LLC	United States	–	registered

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