Pure Global AI
China NMPA legacy archive 国械注准20253060067

Endovascular ultrasound diagnostic equipment

血管内超声诊断设备
Sonoscape MEDICAL Corp.Class IIINMPAApproved January 10, 2025
Static archiveNMPA · legacy registration snapshot
Device classification
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 information
Registration number
国械注准20253060067
Approval date
January 10, 2025
Expiry date
January 09, 2030
Registrant
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 facility
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
Intended use
English

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。

Structure and composition
English

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。

Additional information
Appendix
产品技术要求
About this record

This static archive preserves historical registration fields and translations for Endovascular ultrasound diagnostic equipment, registration 国械注准20253060067. It does not establish current authorization or complete current product details.

The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.