Blood Glucose Uric Acid Cholesterol Analyzer - NMPA Registration 湘械注准20242220805
Access comprehensive regulatory information for Blood Glucose Uric Acid Cholesterol Analyzer 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20242220805 and owned by Fosun Diagnostic Technology (Changsha) Co., Ltd. The device was approved on September 02, 2024.
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.
This product is used in conjunction with matching test strips for in vitro quantitative detection of blood glucose, uric acid and cholesterol concentrations in human fresh fingertip peripheral whole blood or venous whole blood, and can be used for professional testing and non-professional self-testing.
本产品与配套试纸条配合使用，用于体外定量检测人体新鲜指尖末梢全血或静脉全血中的血糖、尿酸和胆固醇浓度，可用于专业人员检测和非专业人员自测。
The product consists of a host, accessories, and embedded software modules. Mainframe: circuit board, function keys, test strip connectors, housing, and communication module (configured according to model). Accessories: blood collection pen (qualified product that has obtained medical device registration certificate), battery (optional, in line with GB/T8897.2 requirements). Embedded software modules: system control module, power management module, data storage module, human-computer interaction module, data transmission module (GUC-2ble, GUC-2nb).
产品由主机、配件、嵌入式软件模块组成。主机:电路板、功能键、试纸条连接器、外壳和通讯模块(根据型号配置) 。配件:采血笔(已取得医疗器械注册证的合格产品)、电池(选配,符合GB/T8897.2 要求)。嵌入式软件模块:系统控制模块、电源管理模块、数据贮存模块、人机交互模块、数据传输模块(GUC-2ble、GUC-2nb)。