肌酐测试仪
- 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 number
- 湘械注准20252220012
- Approval date
- January 03, 2025
- Expiry date
- January 02, 2030
- Name
- Sinocare Inc.三诺生物传感股份有限公司
- Province/Region
- Hunan湖南
- Address
- No. 265, Guyuan Road, Changsha High-tech Industrial Development Zone长沙高新技术产业开发区谷苑路265号
- Production address
- 长沙高新技术产业开发区谷苑路265号
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。
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）。
- Appendix
- 产品技术要求
Access comprehensive regulatory information for 肌酐测试仪 in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 湘械注准20252220012 and owned by Sinocare Inc.. The device was approved on January 03, 2025.
This page provides complete registration details including registrant information, province location (Hunan), 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.