Endovascular ultrasound diagnostic equipment
- Device class
- Class III
- Model specifications
- V20i、V20i Pro、V20i Exp
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20253060067
- Approval date
- January 10, 2025
- Expiry date
- January 09, 2030
- Name
- Sonoscape MEDICAL Corp.深圳开立生物医疗科技股份有限公司
- Province/Region
- Guangdong广东
- Address
- 深圳市南山区粤海街道麻岭社区高新中区科技中2路1号深圳软件园 （2期）12栋201、202
- Production address
- 深圳市光明区光明街道东周社区光明高新区东片区双明大道南侧二号路以西开立医疗大厦
在医疗机构中使用，与上海爱声生物医疗科技有限公司生产的一次性使用血管内超声诊断导管（型号：TJ001、CU-S035014B、CU-S035014C、TJ002、TJ002-14A、CU-S036014C、CU-S036014E）配合使用，用于需要进行血管介入治疗患者的冠状动脉超声成像检查。
产品由主机、显示器（DSU-238WC或DSU-215WF）、床旁连接器（BCB20）、导管控制器（C20）、触控面板（TS20）（选配）和键盘（选配）组成。
- Appendix
- 产品技术要求
Access comprehensive regulatory information for Endovascular ultrasound diagnostic equipment in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20253060067 and owned by Sonoscape MEDICAL Corp.. The device was approved on January 10, 2025.
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.