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乐心医疗(300562.SZ):控股子公司完成医疗器械注册证延续注册
Ge Long Hui A P P· 2025-11-26 10:24
Core Viewpoint - Leasen Medical (300562.SZ) announced that its subsidiary, Shenzhen Ruikang Hongye Technology Development Co., Ltd., has received approval from the Guangdong Provincial Drug Administration for the renewal of its medical device registration for the ECG information network management system software [1] Group 1 - The approval pertains to the renewal of the medical device registration certificate [1] - The product involved is the ECG information network management system software [1]
乐心医疗:心电信息网络管理系统软件医疗器械注册证延续至2031年05月26日
Xin Lang Cai Jing· 2025-11-26 10:08
Core Viewpoint - The announcement indicates that the medical device registration extension for the ECG information network management system software has been approved, extending its validity until May 26, 2031 [1] Group 1 - The ECG information network management system software was originally set to expire on May 26, 2026, and has now been extended for an additional five years [1] - The software consists of a system installation CD and random system files, designed for receiving, viewing, editing static and dynamic ECG data, printing reports, and statistical data functions, but does not include automatic diagnosis features [1]
乐心医疗:关于控股子公司延续医疗器械注册证获得受理的公告
Zheng Quan Ri Bao· 2025-11-10 14:15
Group 1 - The core point of the article is that Leshi Medical announced that its subsidiary, Shenzhen Ruikang Hongye Technology Development Co., Ltd., has received acceptance for the renewal of a medical device registration certificate from the Guangdong Provincial Drug Administration for its product, the ECG Information Network Management System Software [2] Group 2 - The acceptance number for the application is 0010600220251129, indicating that the regulatory process is underway for the product [2]
乐心医疗(300562.SZ):控股子公司延续医疗器械注册证获得受理
Ge Long Hui A P P· 2025-11-10 12:02
Core Viewpoint - Le Xin Medical (300562.SZ) announced that its subsidiary, Shenzhen Ruikang Hongye Technology Development Co., Ltd., has received an acceptance certificate from the Guangdong Provincial Drug Administration for the renewal of its medical device registration for the ECG information network management system software [1] Group 1 - The product is named "ECG Information Network Management System Software" and consists of a system software installation disc and accompanying files [1] - The software is designed for receiving, viewing, editing static and dynamic ECG data, printing reports, and statistical data functions, but does not include automatic diagnosis features [1]
乐心医疗:控股子公司延续医疗器械注册证获得受理
Ge Long Hui· 2025-11-10 11:48
Core Viewpoint - Le Xin Medical (300562.SZ) announced that its subsidiary, Shenzhen Ruikang Hongye Technology Development Co., Ltd., has received a receipt from the Guangdong Provincial Drug Administration regarding the acceptance of its application for the renewal of a medical device registration certificate for its ECG information network management system software [1] Group 1 - The medical device registration certificate application pertains to the ECG information network management system software [1] - The software includes a system installation CD and accompanying files, designed for receiving, viewing, editing static and dynamic ECG data, printing reports, and statistical data functions [1] - The software does not include automatic diagnosis features [1]