Against the backdrop of growing adoption of minimally‑invasive diagnostic and therapeutic techniques in urology, the domestic localization of endoscopic devices has reached a critical juncture. The flexible ureterorenoscope launched by Wolf Medical Device Manufacturing (Taicang) Co., Ltd., a flagship product under the localization strategy of Richard Wolf (Germany), has recently obtained formal Class II medical device registration with registration certificate No. Su Xie Zhu Zhun 20262060990. A previously publicly available registration certificate for the same type of flexible ureterorenoscope is Su Xie Zhu Zhun 20262060230. The two registrations likely correspond to filings for different batches or models of the same product.
This flexible ureterorenoscope is a visualization‑oriented endoscopic device specifically designed for urological procedures. It accesses the ureter and renal regions entirely via the body’s natural orifice — the urethra — without requiring additional surgical incisions, making it a typical minimally‑invasive diagnostic and therapeutic instrument.
In clinical diagnostic settings, it can directly reach the interior of the ureter and renal pelvis, delivering clear visualization of lesion details. It assists physicians in accurately identifying the causes of hematuria and screening for various ureteral pathologies, addressing the pain point that conventional imaging examinations cannot provide direct intraluminal observation.
During therapeutic procedures, leveraging its real‑time visual imaging capability, the scope can work with supporting instruments to perform multiple interventions including ureteral stone extraction, ureteral stricture dilation, ureteral hydronephrosis drainage, and diagnosis and treatment of ureteral tumors. It significantly reduces procedural trauma for patients and shortens postoperative recovery time.
This product shall be used in conjunction with an endoscopic camera system and endoscopic cold‑light source during operation to ensure imaging clarity and smooth procedural performance.
As a reusable optical endoscope, this product is subject to clear and stringent technical specifications. Its overall structure consists of four key components: the scope body, eyepiece cover, insertion valve and light‑guide connector, enabling adaptation to diverse clinical diagnostic and therapeutic requirements.
In terms of core performance, the product adopts optical fiber image‑transmission technology. Its objective lens features a highly wear‑resistant sapphire lens, while the scope body is made of lightweight, high‑strength titanium metal, balancing durability and handling ergonomics. Supplied in a non‑sterile condition, the device is compatible with high‑temperature and high‑pressure sterilization for multiple re‑uses. While ensuring clinical safety, it effectively cuts operational costs for medical institutions.
The global ureteroscope market is currently on a steady growth trajectory. Forecasts from multiple industry institutions indicate that the global flexible and semi‑rigid ureteroscope market reached USD 0.9‑2.75 billion in 2025, and is projected to expand further to USD 1.15‑4.38 billion by 2032, with a compound annual growth rate (CAGR) ranging from 6% to 8%. A separate specialized report focusing on rigid flexible ureterorenoscopes estimates that global revenue for this segment stood at approximately USD 591 million in 2024 and is expected to climb to USD 840 million by 2031.
The core drivers behind market growth stem from two factors. First, the global incidence of urological diseases, particularly nephrolithiasis (kidney stones), keeps rising, unleashing growing patient demand for diagnosis and treatment. Second, the rapid adoption of minimally‑invasive surgical concepts in urology has driven sustained improvement in the clinical penetration rate of endoscopic devices.
China, boasting one of the world’s largest population bases and fastest‑growing medical demands, has long become a core strategic battleground for global urological endoscopy manufacturers. High‑quality products developed and manufactured domestically enjoy extremely broad development prospects.
Wolf Medical Device Manufacturing (Taicang) Co., Ltd. serves as the core entity for implementing the localization strategy in China by Richard Wolf, the renowned German urological endoscopy brand. Located in Taicang City, Jiangsu Province, it undertakes key functions for local R&D, production and supply of the brand’s products.
The approval and launch of this flexible ureterorenoscope marks a landmark milestone in Richard Wolf’s advancement of its “domestic manufacturing” strategy in China. Rather than lowering quality standards for local‑based production, the product fully retains Richard Wolf’s globally unified high‑quality quality control system, while achieving in‑depth integration of R&D and manufacturing processes with domestic clinical requirements.
The granting of this Class II medical device registration means the product has obtained qualifications for official sales in the Chinese domestic market. It not only further enriches the brand’s product portfolio in China’s urological endoscopy sector, but also demonstrates Richard Wolf’s firm commitment to long‑term dedication to the Chinese market and serving local clinical practices and patients. Going forward, the full‑scale roll‑out of this product will deliver more cost‑effective high‑quality options for minimally‑invasive urological diagnosis and treatment across China.
