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China NMPA legacy archive 粤械注准20242061019

Electronic ureteronephroscopory

电子输尿管肾盂内窥镜
Sonoscape MEDICAL Corp.Class IINMPAApproved July 31, 2024
Static archiveNMPA · legacy registration snapshot
Device classification
Device class
Class II
Model specifications
EUC-110S、EUC-X20S
Approval department
Guangdong Provincial Drug Administration
广东省药品监督管理局
Registration information
Registration number
粤械注准20242061019
Approval date
July 31, 2024
Expiry date
July 30, 2029
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
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 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

It is used in medical institutions in conjunction with image processing devices manufactured by this manufacturer for imaging in the observation, diagnosis, and treatment of the urethra, bladder, ureter, and renal pelvis. Not to be used with high-frequency accessories.

中文

在医疗机构中与本制造商生产的图像处理装置配合使用,用于尿道、膀胱、输尿管、肾盂的观察、诊断和治疗中成像。不可与高频配件配合使用。

Structure and composition
English

The product consists of an electronic ureteral pelvic endoscope and accessories, including a clamp valve (VB-102CY) and a clamp perfusion joint (VBI-102CY).

中文

该产品由电子输尿管肾盂内窥镜及附件组成,附件包括钳道阀(VB-102CY)、钳道灌流接头(VBI-102CY)。

Additional information
Appendix
产品技术要求
About this record

This static archive preserves historical registration fields and translations for Electronic ureteronephroscopory, registration 粤械注准20242061019. 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.