Huawei officially approved to start manufacturing medical devices

According to the information, the Guangdong Food and Drug Administration released the list of products approved for the pilot program of the Guangdong Medical Device Registrant System (as of October 8, 2021). Huawei’s wrist single-lead ECG collector production is officially approved, the registration number is: Guangdong Machinery Zhuzhun 20202071705, the trustees are Goertek Co., Ltd. and Weifang Jingwei High-Tech Electronic Technology Co., Ltd.

Huawei also has three medical devices that have entered the priority approval process. They are wrist ECG blood pressure recorder (MLY-B10, MLY-B11), ECG analysis system (ECG-1), arrhythmia analysis system (PPG-1).

It is worth mentioning that as early as May this year, “He Gang”, president of Huawei’s consumer business mobile phone product line, posted on Weibo that Huawei’s first smartwatch that can measure blood pressure has passed the medical device registration test.

On September 6, Huawei also opened the recruitment of blood pressure test subjects through its member app, requiring a wrist circumference greater than 200 mm and a blood pressure higher than 140 mmHg priority.

Huawei is currently developing wearable blood pressure measurement equipment with home medical-grade high-precision blood pressure measurement as the core. At the same time, Huawei and well-known domestic institutions have launched research on hypertension management to explore innovative initiatives in blood pressure from screening to early intervention.

According to Huawei’s official display, Huawei Medical has currently served more than 3,000 medical and health service organizations. To provide the medical industry with comprehensive coverage, safe and controllable, simple operation and maintenance, and future-oriented wireless network solutions.