Hanuo Medical's Lifemotion ECMO System Becomes First Domestic Full-System ECMO to Obtain EU CE MDR Certification
Domestic ECMO Achieves Major Breakthrough.
As the Spring Festival approaches,Shenzhen Hanuo Medical Technology Co., Ltd. (hereinafter referred to as “Hanuo Medical”) has successfully obtained certification under the European Union’s Medical Device Regulation (MDR) for its independently developed domestic ECMO system. It is the first complete ECMO system globally to receive CE certificates for four registration units simultaneously under the EU MDR, and also the first fully self-developed domestic complete ECMO system to obtain overseas certification.
The Hanovo Medical Lifemotion ECMO (Extracorporeal Membrane Oxygenation) System, recently approved for market entry, comprises four products: an extracorporeal cardiopulmonary support device, a disposable membrane oxygenator kit, a disposable membrane oxygenator, and a disposable centrifugal pump head. The approved indications cover multiple scenarios, including in-hospital adjunctive support and inter-hospital transport via ambulance. With the approved ECMO kit designed for use up to 14 days, the system meets the majority of clinical needs and robustly supports the effective delivery of various critical care interventions.
Hannuo Medical’s ECMO Product Successfully Obtains EU MDR Certification: A Strong Endorsement of the Quality, Safety, and Efficacy of China’s High-End Medical Equipment, Signaling the Further Rise of China’s Premium Medical Device Industry and Marking a Significant Step Forward for Chinese Extracorporeal Life Support Technology on the Global Stage
It is worth noting that Hannuo Medical’s complete ECMO system is the first domestically produced ECMO system to obtain CE certification after the EU MDR regulation came into effect. Under the MDR framework, obtaining the CE mark is highly challenging and carries significant prestige.
In 2017, the EU CE certification for medical devices was upgraded from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR), which came into effect on May 26, 2021. Compared with the MDD, the MDR imposes stricter regulatory requirements. The establishment of a medical device identification system and database has enhanced transparency and traceability throughout the lifecycle of medical devices, while strengthening post-market surveillance and manufacturers’ responsibilities.The series of new and more detailed requirements also means that obtaining the CE mark for medical devices under the MDR regulation is more difficult, with longer review and approval cycles. Industry practitioners even believe that the difficulty of passing the EU CE certification under the MDR regulation is no less than that of passing the US FDA approval.
In fact, the approval of ECMO devices in the European Union faces a more unique situation:As the birthplace of ECMO product development and manufacturing technologies, as well as the global standard-setter for ECMO technical specifications, Europe maintains the world’s most stringent regulatory review standards. This inevitably further increases the difficulty of obtaining approval for ECMO devices.—Companies must align with, or even surpass, the most advanced technical standards for ECMO products to have a realistic chance of obtaining regulatory approval.
Ultimately, Hanuo Medical’s domestically produced ECMO complete system has secured the initial CE certification under the EU Medical Device Regulation (MDR). This achievement not only represents a high level of recognition for the quality, safety, and efficacy of China’s high-end medical equipment, indicating that China’s R&D and manufacturing technologies for high-end medical devices have reached world-class standards, but also marks China’s acceptance in the ECMO field by the region with the most stringent review standards and extensive expertise globally. While showcasing the innovative strength of China’s high-end medical equipment, it further highlights the international competitiveness of Chinese-made devices.
With domestically produced ECMO devices obtaining EU MDR certification, this will undoubtedly further enhance China’s influence in the international ECMO market, strengthen global recognition of Chinese medical devices, and further reduce the country’s long-standing reliance on imported ECMO products, thereby safeguarding self-sufficiency and controllability in China’s high-end medical device sector.
Among Domestic ECMO Device Manufacturers, Why Did Hannuo Medical Secure the First CE Certification Under the EU MDR Regulation?
This may be related to the manufacturer's comprehensive strength.
From a technical perspective, the ECMO system presents extremely high technological barriers. The approval of Hanuo Medical’s Lifemotion ECMO System has validated its mastery of the core technologies and capabilities required to develop extracorporeal support devices and consumables.
ECMO is not a single technology but a suite of foundational extracorporeal life support technologies that effectively halt the progression of short- to medium-term respiratory and circulatory failure through artificial heart and lung support, thereby sustaining life and core organ function. These core foundational technologies are transformed into the six key components of an ECMO system—namely, the drive control unit, artificial heart, artificial lung, circulation tubing, vascular cannulas, and anticoagulant coating—through bionic design and high-precision manufacturing processes, resulting in exceptionally high barriers to the research and development of both equipment and consumables.
Hanno Medical has achieved breakthroughs in the core key technologies of extracorporeal life support, enabling independent control and mass production of core components. On January 4, 2023, Hanno Medical’s self-developed ECMO system, the first domestically produced set of its kind, received market approval. In July 2023, two additional core products—the disposable centrifugal pump head and the disposable membrane oxygenator—were also approved. Hanno Medical is currently one of the few Chinese manufacturers to have obtained approvals and achieved sales for both ECMO equipment and the full range of system consumables.
Guided by clinical needs, Hanovo Medical’s Lifemotion ECMO system emphasizes safety, portability, and intelligence to facilitate the efficient implementation of extracorporeal life support in clinical practice. It features a globally innovative and leading dual electric pump design with integrated flow display and alarm functions, providing a safer and more reliable cardiopulmonary support solution for clinical use. The system adopts a power supply scheme comparable to that of artificial heart devices, significantly enhancing portability and enabling faster patient transfer, thereby securing valuable time for emergency rescue. The approved ECMO circuit kit supports up to 14 days of use, reflecting thorough consideration of clinical requirements.
From a market perspective, the clinical deployment of products enables real-world data studies and helps companies recoup capital for product upgrades and iterations, thereby facilitating overseas regulatory approvals. Hanuo Medical enjoys a unique first-mover advantage.
In January 2023, Hannuo Medical secured the first regulatory approval for a domestically produced ECMO system in China, taking the lead in the ECMO sector and rapidly advancing its hospital adoption. It is reported that Hannuo Medical’s Lifemotion ECMO system has won bids for over 100 units in China. Data from Yifangbao, a third-party platform for bidding and procurement information, shows that Hannuo Medical’s Lifemotion ECMO devices ranked first in terms of the number of successful bids in the newly added domestic market in 2024, surpassing imported brands and capturing more than one-third of the market share. Major winning institutions include key Grade-A tertiary hospitals such as Beijing Anzhen Hospital affiliated with Capital Medical University, West China Hospital of Sichuan University, The First Affiliated Hospital of Sun Yat-sen University, Shanghai Chest Hospital, and Sichuan Provincial People’s Hospital, as well as selected other tertiary and secondary hospitals, benefiting thousands of patients.
The accumulation of early-stage technological expertise and innovative exploration following product commercialization have further propelled the new development of Hannuo Medical. Hannuo Medical stated, “Starting with extracorporeal cardiopulmonary support, we will continue to develop products horizontally in areas such as longer-lasting ECMO devices and consumables, support for chronic organ failure, and combined support for multi-organ failure. Vertically, we will continuously deepen our industrial chain by expanding upstream core technologies, midstream products, and downstream medical services.”
From an industry perspective, driving innovative development is the responsibility of leading enterprises in the ECMO field. Hainuo Medical has been consistently committed to supporting the growth of the industry.
On the one hand, Hanuo Medical is actively promoting the development of the promotion and application of ECMO technology in China.In December 2024, Hanuo Medical, in collaboration with Beijing Anzhen Hospital of Capital Medical University and seven other top-tier domestic ECMO clinical centers, undertook the Extracorporeal Membrane Oxygenation (ECMO) Machine Promotion and Application Project issued by the Ministry of Industry and Information Technology (MIIT) and the National Health Commission (NHC). Participating medical institutions included Beijing Chaoyang Hospital of Capital Medical University, the First Affiliated Hospital of Zhejiang University School of Medicine, Sichuan Provincial People’s Hospital, Jiangsu Province Hospital, the Second Affiliated Hospital of Zhejiang University School of Medicine, the First Affiliated Hospital of Guangzhou Medical University, and the Affiliated Hospital of Zunyi Medical University.
On the other hand, Hanovo Medical continues to make its presence felt on the global academic stage, sharing the latest research findings.2023–2024: Hannuo Medical Frequently Appeared on Domestic and International Academic Stages, Actively Participated in Major Academic Conferences, and Published Significant Academic AchievementsFrom 2023 to 2024, Hannuo Medical made frequent appearances on domestic and international academic stages, actively participated in major academic conferences both at home and abroad, and published significant academic achievements. These include, but are not limited to, the following: In April 2023, Hannuo Medical was the only Chinese enterprise to exhibit at the 11th Annual Meeting of the European Extracorporeal Life Support Organization (EuroELSO). In April 2024, it was again the sole Chinese company to host an academic thematic forum at the 12th EuroELSO Annual Meeting. In June of the same year, Hannuo Medical appeared at the 70th Annual Meeting of the American Society for Artificial Internal Organs (ASAIO), showcasing its latest scientific research outcomes. Hannuo Medical highlighted insights into the development trend toward greater portability of ECMO devices and demonstrated that high-risk percutaneous coronary intervention (PCI) procedures supported by veno-arterial extracorporeal membrane oxygenation (VA-ECMO) can effectively improve cardiac function and patient prognosis.
Hannuo Medical’s robust comprehensive strength, coupled with its continuous contributions to the industry’s innovative development, has brought the company into the spotlight. Ultimately, the outstanding performance of its Lifemotion ECMO system enabled Hannuo Medical to obtain CE certification under the EU’s Medical Device Regulation (MDR), allowing the company to gain global recognition.
According to Frost & Sullivan’s projections, the global ECMO market size is expected to exceed RMB 10 billion by 2030. The ECMO market demonstrates immense development potential. Meanwhile, the expansion of application scenarios has directly driven a surge in demand for ECMO treatment services, boosting the estimated value of the global therapeutic services market to USD 10 billion.
The global market for ECMO technology application is rapidly expanding into diverse clinical scenarios. From its traditional roles in supporting cardiac surgery and treating severe respiratory failure, ECMO use has progressively extended to perioperative support for high-risk interventional cardiology procedures, combined therapy for multi-organ failure, donor organ preservation in transplantation, and pre-hospital emergency care. Meanwhile, technological advancements such as portable ECMO devices and intelligent management systems are further broadening the boundaries of clinical applicability.
Source: Chinese Medical Doctor Association Extracorporeal Life Support Professional Committee, “2023 China ECMO Survey Report”
From the perspective of China, the "2023 China ECMO Survey Report" released by the Extracorporeal Life Support Professional Committee of the Chinese Medical Doctor Association shows that from 2004 to the end of 2023, the number of extracorporeal life support centers in China has increased nearly 40-fold, rising from 22 to 814; meanwhile, the total number of ECMO cases performed has also grown from 23 to the current 18,486.
Globally, according to data from the Extracorporeal Life Support Organization (ELSO), the number of ECMO centers and procedures performed worldwide achieved a compound annual growth rate (CAGR) of nearly 12% from 2017 to 2023. Currently, North America and Europe maintain their technological leadership through a high density of ECMO centers, while emerging markets such as China and Latin America are becoming the core drivers of global market expansion by establishing regional ECMO treatment networks and training systems, forming a dual-wheel growth pattern characterized by "technological application innovation + decentralization of medical services."
However, in this market with continuously growing demand, the supply of ECMO devices and consumables has encountered significant challenges. In recent years, leading international ECMO manufacturers have frequently faced product recalls and production halts, severely impacting the clinical use of ECMO equipment and supplies and causing acute supply shortages. Addressing the divergent needs between emerging and mature markets has become an unavoidable challenge for the industry.
Nowadays,With Hano Medical’s ECMO system obtaining CE certification under the EU MDR regulations, it signifies that domestically produced complete ECMO systems have secured a “passport” to enter the European market. Furthermore, it grants market access in nearly 50 countries and regions, covering a population of over 2 billion, that recognize CE certification. This will undoubtedly facilitate the expansion of Chinese-made ECMO equipment into the global market and help better address current supply shortages of ECMO devices and consumables.
Hannuo Medical also stated, “While establishing our presence in China and addressing the critical challenges associated with domestic extracorporeal cardiopulmonary support technology, we will accelerate our expansion into overseas markets based on robust clinical research, thereby embarking on a path toward global scale. Leveraging our NMPA and CE certifications, Hannuo Medical aims to provide extracorporeal life support products and services to over 100 countries and regions worldwide, covering a population of more than 4 billion.”
In the field of extracorporeal life support, Chinese manufacturers of ECMO devices will leverage their unique advantages to contribute Chinese wisdom. With the rise of domestic high-end medical equipment enterprises, China will continue to exert its influence in the global healthcare sector, drive technological innovation, demonstrate our scientific and technological prowess, and contribute Chinese strength to the global health cause.