Core Viewpoint - Haier Biomedical's subsidiary, Haier Blood Technology Chongqing Co., Ltd., has received the first EU MDR certification for its plasma separation equipment, marking a significant milestone for the company in expanding its market presence in Europe and globally [2][5]. Group 1: Certification and Compliance - The MDR compliance assessment is a prerequisite for medical devices entering the EU market, ensuring product safety, performance, and post-market surveillance [5]. - The successful certification of Haier's plasma separation equipment demonstrates the company's adherence to EU regulations in product design, manufacturing, and quality control [5]. Group 2: Company Statements and Future Plans - Haier Biomedical's General Manager, Liu Zhanjie, emphasized that obtaining the MDR certificate is a recognition of the company's quality management system and positions Haier Blood Technology to compete globally [7]. - The company aims to leverage this certification as a new starting point to promote Chinese manufacturing solutions in global healthcare [7]. Group 3: TÜV Rheinland's Role - TÜV Rheinland serves as a notified body for EU medical device regulations, providing compliance assessments and certifications that enhance the competitiveness of "Made in China" products in international markets [8]. Group 4: Company Overview - Haier Blood Technology Chongqing Co., Ltd. was established in 2001 and specializes in comprehensive solutions for blood and blood component collection, processing, testing, storage, transportation, and usage [8]. - The company's main products include plasma separation machines, disposable centrifuge plasma separators, and various types of blood bags and related medical devices [8].