ECG Analysis Software - NMPA Registration 国械注准20243211562
Access comprehensive regulatory information for ECG Analysis Software in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20243211562 and owned by Edan Instruments, Inc.. The device was approved on August 23, 2024.
This page provides complete registration details including registrant information, province location (Guangdong), 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.
Used in conjunction with validated resting ECG devices for the reception, storage, display, management, and analysis of ECGs in the resting state in adults and children. ECG analysis software provides automatic measurement of resting ECG, interpretive analysis of ECG rhythm and morphological heart disease including normal ECG, atrial hypertrophy and ventricular hypertrophy, arrhythmia and pacing ECG, myocardial infarction and ST-T changes. The results of the analysis are only used as a diagnostic reference, and the licensed physician must combine the expertise of the ECG, the results of all examinations, and the clinical experience and past medical history of the patient as well as clinical symptoms to make the final diagnosis.
与经验证的静态心电设备配合使用，用于成人和儿童静息状态下心电图的接收、存储、显示、管理以及分析。心电分析软件可对静态心电图进行自动测量、包括正常心电图、心房肥大及心室肥厚、心律失常及起搏心电图、心肌梗死及ST-T改变在内的心电图节律和形态学心脏疾病解释性分析。分析结果仅作为诊断参考，执业医师必须结合心电图专业知识，综合所有检查结果，结合临床经验和患者既往病史以及临床症状，做出最终诊断。
The product consists of a software installation file. The functional modules include: server side (including deep learning algorithm analysis module, data storage module, interface service module) and client (including system administrator module, appointment registration module, data receiving and display module, report/printing module, data statistics module, data management module, auxiliary analysis tool module, query module).
产品由软件安装文件组成。功能模块包括：服务器端（包括深度学习算法分析模块、数据存储模块、接口服务模块）和客户端（包括系统管理员模块、预约登记模块、数据接收与显示模块、报告/打印模块、数据统计模块、数据管理模块、辅助分析工具模块、查询模块）。