Fully automatic coagulation analyzer - NMPA Registration 冀械注准20222220463
Access comprehensive regulatory information for Fully automatic coagulation 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 冀械注准20222220463 and owned by Langfang Hengyi Biotechnology Co., Ltd.. The device was approved on December 05, 2022.
This page provides complete registration details including registrant information, province location (Hebei), 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.
It is suitable for coagulation testing of plasma by coagulation method (magnetic bead method), immunoturbidimetric method and chromogenic substrate method. Assays include plasma prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (FIB), thrombin time (TT) (magnetic bead method), D-dimer (D-Dimer), fibrin (proto) degradation product (FDP) (immunoturbidimetry), antithrombin III. (AT III.) (chromogenic substrate method).
适用于临床采用凝固法（磁珠法）、免疫比浊法及发色底物法对血浆进行凝血测试。检测项目包括血浆凝血酶原时间（PT）、活化部分凝血活酶时间（APTT）、纤维蛋白原（FIB）、凝血酶时间（TT）（磁珠法），D-二聚体（D-Dimer）、纤维蛋白(原)降解产物（FDP）（免疫比浊法），抗凝血酶Ⅲ（AT Ⅲ）（发色底物法）。
It is composed of automatic sample injection unit, detection unit, control unit, data processing and program software.
由自动进样单元、检测单元、控制单元、数据处理、程序软件组成。