Electronic cholangiopancreatography
- Device class
- Class II
- Model specifications
- ECH-110S、ECH-X20S
- Approval department
- Guangdong Provincial Drug Administration广东省药品监督管理局
- Registration number
- 粤械注准20242060654
- Approval date
- May 15, 2024
- Expiry date
- May 14, 2029
- 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
- Shenzhen Software Park (Phase 2), Building 12, 201, 202, No. 1, Keji Middle Road, High-tech Middle District, Maling Community, Yuehai Street, Nanshan District, Shenzhen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
在医疗机构中与本制造商生产的图像处理装置配合使用，用于通过视频监视器为胆道胆管的观察、诊断和治疗提供图像。
本产品由电子胆道内窥镜（型号：ECH-110S、ECH-X20S）、钳道阀（型号：VB-102CY）、吸引阀（型号：VS-501B）、钳道灌流接头（VBI-102CY）组成。
- Appendix
- 产品技术要求
Access comprehensive regulatory information for Electronic cholangiopancreatography 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20242060654 and owned by Sonoscape MEDICAL Corp.. The device was approved on May 15, 2024.
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.