Wanmai Medical DS/VM/DF Series Ventilators Obtain EU MDR Certification for European Market Access

On July 28,2026, Wanmai Medical's DS/VM/DF series ventilators officially obtained the EU MDR certification, marking the successful completion of the rigorous review under the EU's latest medical device regulations for the company's core ventilator products. This achievement grants the company a new passport to enter the European market and represents another milestone in Wanmai Medical's global expansion strategy.

Hardcore Certification

Demonstrating the product's global competitiveness

The EU MDR Regulation stands as one of the most stringent regulatory entry standards in the global medical device sector. Compared with the previous MDD Directive, it imposes higher requirements regarding clinical evidence for products, risk management, whole-life-cycle quality management, and post-market surveillance; its certification audit process is lengthy, its review criteria are comprehensive, and the validity of its certificates is widely recognized across the global industry.

Obtaining the MDR certificate signifies that Wanmai Medical's DS/VM/DF series ventilators demonstrate their safety, efficacy, and product performance, fully complying with the stringent medical standards of the European Union, enabling these products to be legally marketed and distributed across all member states of the EU and the European Economic Area. This achievement not only serves as an authoritative endorsement of the company's R&D capabilities, production control system, and clinical validation expertise, thereby further enhancing the overall competitiveness of Wanmai's products in the global market, but also holds the potential to provide overseas patients with sleep-related respiratory disorders with high-quality domestic ventilation and diagnostic solutions, while promoting the global expansion of Chinese medical device brands.

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Deep roots and accumulated experience

Craftsmanship builds a global reputation.

With years of dedicated expertise in the respiratory health sector, Wanmai Medical has consistently prioritized quality and continuously enhanced its product's core technical capabilities. Previously, the company has obtained numerous authoritative certifications both domestically and internationally, including ISO 13485 Quality Management System certification, MHRA registration in the UK, MDMA certification in Saudi Arabia, ANVISA certification in Brazil, and INVIMA certification in Colombia; its products are exported to multiple countries and regions worldwide and have earned widespread recognition from medical institutions and end-users both domestically and internationally.

Each certification serves as the most compelling testament to the enterprise's steadfast commitment to craftsmanship, while simultaneously reinforcing its solid foundation for expanding globally.

Still Walking

Empowering Global Respiratory Health

Starting from a new foundation and embarking on a new journey, obtaining the MDR certification represents not only recognition but also a responsibility. In the future, Wanmai Medical will continue to uphold its corporate philosophy of "providing outstanding products and services to global users," steadily increase investment in R&D innovation, strictly adhere to global high-standard medical regulations, refine respiratory diagnostic and therapeutic equipment that is safe, reliable, and delivers excellent performance, empower global healthcare with Chinese technology and Chinese intelligent manufacturing, and strive tirelessly for the cause of respiratory health for all humanity.