Oxygen concentrator has passed CE with zero defects

2024-7-16

Recently, yuwell has accepted a Conformite Europeenne (CE) flight inspection, with products such as oxygen concentrators and oxygen regulating valves passing the audit with zero defects. It is worth noting that previously, yuwell had passed the US FDA audit, which means yuwell has been recognized by global authoritative certification bodies for its persistence in quality products.

NMPA, CE, and US FDA are the three major authoritative regulatory and certification bodies in the medical device field. They carry out certification management and quality audit for enterprises with the most rigorous industry quality standards. "Flying inspection" means surprise casual inspection that can best reflect the real quality management level of an enterprise.

It is reported that this time the CE "flying inspection" rigorously reviewed raw material procurement, production process, process control, quality management, sales management, and other links of the yuwell oxygen concentrator to conduct a comprehensive evaluation.

As a global family health management expert, yuwell has served 300 million users and 300,000 medical institutions worldwide. Since its creation in 1998, yuwell has aimed at becoming a beacon enterprise in the enabling industry.

As the core product of yuwell, the oxygen concentrator has been awarded the MSCA and RDDA by MIIT and inscribed on the 2020 enterprise standard "leader” list. According to CCTV, yuwell is one of the world's largest manufacturers for oxygen concentrators and plays an important role in the global oxygen generation industry.

Yuwell oxygen concentrators reported by CCTV

Medical devices are closely related to life. Therefore, their stability and accuracy are crucial. Alex Wu, CEO of yuwell, said in an exclusive interview with the media, “Over the past 20 years, yuwell has given top priority to quality management. In the future, it will remain committed to high-quality management in the links such as production, R&D, and after-sale services.”

High-quality management advances high-quality development. In recent years, as the construction of the yuwell global industrialization base and global testing center was completed, intelligent production and digital management have brought new drivers for the improvement of yuwell’s product quality, according to public records.

Yuwell global testing center has obtained the qualification of CNAS and WTDP laboratory, an authoritative certification organization in the U.S., which marks that yuwell hardware facilities, quality management, and testing ability have reached the internationally recognized level. Meanwhile, the blood pressure monitor, oxygen concentrator and blood glucose meter, and other multiple products of yuwell all have acquired the CE and US FDA certification. Yuwell has taken on multiple national key research and development plans, providing quality guarantees for domestic and international business and clinical research.

Data show that China has become the world's largest manufacturing country for 11 consecutive years and built the world's largest 5G mobile network. We believe that in the future, a growing number of Chinese enterprises will comprehensively contribute to China's high-quality development and lead global industrial innovation and exchanges with excellent quality and craftsmanship.