Silicone ureteral stent kit
- Device class
- Class II
- Model specifications
- SUS-DJ-620、SUS-DJ-622、SUS-DJ-624、SUS-DJ-626、SUS-DJ-628、SUS-DJ-630、SUS-DJ-722、SUS-DJ-726、SUS-DJ-728、SUS-DJ-8522、SUS-DJ-8524、SUS-DJ-8524、SUS-DJ-8526、SUS-DJ-8528.SUS-DJ-620、SUS-DJ-622、SUS-DJ-624、SUS-DJ-626、SUS-DJ-628、SUS-DJ-630、SUS-DJ-722、SUS-DJ-724、SUS-DJ-726、SUS-DJ-728、SUS-DJ-8522、SUS-DJ-8524、SUS-DJ-8526、SUS-DJ-8528。
- Approval department
- Guangdong Provincial Drug Administration广东省药品监督管理局
- Registration number
- 粤械注准20232141860
- Approval date
- November 13, 2023
- Expiry date
- November 12, 2028
- Name
- Well Lead Medical Co., Ltd.广州维力医疗器械股份有限公司
- Province/Region
- Guangdong广东
- Address
- No. 4, Area C, Jinhu Industrial City, Hualong Town, Panyu District, Guangzhou广州市番禺区化龙镇金湖工业城C区4号
- Production address
- 广州市番禺区化龙镇金湖工业城C区4号，广州市番禺区化龙镇国贸大道南45号、47号
Used to treat blocked and narrow ureters by supporting and draining the body's ureters. Stays in the body for less than 30 days.
通过对人体输尿管进行支撑和引流，用于治疗输尿管堵塞和狭窄。在体内滞留时间小于30天。
The silicone ureteral stent kit consists of a silicone ureteral stent, booster tube, and guidewire (optional). Silicone ureteral stents are made of silicone rubber, guidewires are made of stainless steel, polytetrafluoroethylene (PTFE) coating, and booster tubes are made of polypropylene (PP).
硅胶输尿管支架套件由硅胶输尿管支架、助推管和导丝（选配）组成。硅胶输尿管支架由硅橡胶制成；导丝由不锈钢、聚四氟乙烯（PTFE）涂层制成；助推管由聚丙烯（PP）制成。
- Appendix
- 产品技术要求
Access comprehensive regulatory information for Silicone ureteral stent kit in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 粤械注准20232141860 and owned by Well Lead Medical Co., Ltd.. The device was approved on November 13, 2023.
This page provides complete registration details including registrant information, province location (Guangdong), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.