Jiangxi Haier Medical Technology Co., Ltd.

Jiangxi Haier Medical Technology Co., Ltd. specializes in producing medical devices under the Haier brand, focusing on diagnostic imaging systems and patient monitoring equipment. Their portfolio includes ultrasound machines and other clinical diagnostic tools designed for use in hospitals and healthcare environments. These devices are developed to assist healthcare professionals in accurate diagnosis and patient care.

Jiangxi Haier Medical Technology Co., Ltd. is based in China. While the company operates from this location, its devices are intended for global markets, including the European Union, where they must comply with regional regulatory requirements.

Devices from Jiangxi Haier Medical Technology Co., Ltd. are listed in the EUDAMED registry. This database is used to track medical devices placed on the European market, ensuring transparency and compliance with EU regulations. Listing in EUDAMED is a requirement for devices marketed in the EU.

Under EU medical device regulations, devices manufactured by Jiangxi Haier Medical Technology Co., Ltd. fall under Class IIa. This classification is determined based on the risk associated with the device’s intended use and design. Class IIa devices pose a moderate risk and require compliance with specific regulatory requirements, including conformity assessment procedures, to ensure safety and performance before market placement.