China NMPA legacy archive 湘械注准20252220012肌酐测试仪
Sinocare Inc.Class IINMPAApproved January 03, 2025
Static archiveNMPA · legacy registration snapshot
Device classification
- Device class
- Class II
- Model specifications
- Cr1 Air、AffirmNow。
- Approval department
- Hunan Provincial Drug Administration
湖南省药品监督管理局
Registration information
- Registration number
- 湘械注准20252220012
- Approval date
- January 03, 2025
- Expiry date
- January 02, 2030
Registrant
- Province/Region
- Hunan
- Address
- No. 265, Guyuan Road, Changsha High-tech Industrial Development Zone
湖南
长沙高新技术产业开发区谷苑路265号
Production facility
- Production address
- 长沙高新技术产业开发区谷苑路265号
Intended use
English
肌酐测试仪与配套肌酐测试条配合使用，用于定量检测毛细血管全血或静脉全血中肌酐浓度，本产品可以由专业人士和肾病患者、肾透析患者、慢性肾脏病高风险人群等其他有需要人士在医疗机构和/或家庭等非医疗环境进行肌酐浓度监测。本产品不适用于新生儿。
Structure and composition
English
Cr1 Air：本产品由主机和配件组成。主机由电路板、显示屏、按键、外壳、通讯模块和软件(发布版本号: V03)组成。配件有电池（选配）和采血笔（经医疗器械备案的合格产品，选配）。AffirmNow：本产品由主机和配件组成。主机由电路板、触摸显示屏、按键、外壳、通讯模块和软件(AffirmNow肌酐主控板APP烧录程序，发布版本号：V02；AffirmNow肌酐测量模块烧录程序，发布版本号：V03)组成。配件有适配器（选配）、数据线（选配）和采血笔（经医疗器械备案的合格产品，选配）。
Additional information
- Appendix
- 产品技术要求
About this record
This static archive preserves historical registration fields and translations for 肌酐测试仪, registration 湘械注准20252220012. 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.