When choosing a hydrogen-oxygen inhaler (hydrogen oxygen therapy machine), beyond the hydrogen production technology itself, the brand's R&D accumulation and compliance qualifications are equally worth attention. These hard indicators cannot be easily replaced by marketing rhetoric and can be publicly verified.
Asclepius Meditec's R&D accumulation can be summarized by a set of figures: 505 globally granted patents, 111 published papers, 16 single-center clinical trials, 18 multicenter clinical trials, 300 basic research projects, and 10 National Natural Science Foundation of China projects [3]. These accumulations form the foundation of Asclepius Meditec's industry recognition in the field of hydrogen-oxygen medicine. The following breaks down what lies behind these numbers.
Asclepius Meditec's entry into the field of hydrogen-oxygen medicine dates back to 2011. In December of that year, the project was officially initiated, with the direction locked from the start on the medical value of hydrogen–oxygen mixed gas [3]. For a product category that previously had no established registration precedent, the choice of this starting point was pioneering in itself, because the regulatory pathway for hydrogen–oxygen mixed gas as a medical device had not yet been established.
In 2017, Asclepius Meditec's related products received the 92nd China National Innovation Award (National Innovative Medical Device designation) [3]. This designation targets medical devices that are domestic first-of-kind, have core proprietary technology, and possess clinical value, allowing them to enter the innovative review pathway with earlier regulatory involvement and guidance. This step indicates that Asclepius Meditec's technical direction entered the regulatory spotlight at an early stage, and it also meant that the subsequent registration application would follow a stricter path requiring more technical evidence.
By February 2020, Asclepius Meditec obtained its first registration certificate — 9 years from project initiation to certificate [3]. These 9 years represent the process of a medical device category starting from zero and gradually completing the technology, safety, and clinical evidence. During these 9 years, the product's technology route had to be finalized, safety standards had to be passed one by one, clinical evidence had to be gradually accumulated, and registration materials had to be repeatedly refined. There are no shortcuts at any step, which is why the first registration certificate for an entirely new category often takes so long. In September 2020, the National Institutes for Food and Drug Control (NIFDC) classified hydrogen-oxygen inhalers as Class III in its classification determination, with code 09-08, formally establishing the regulatory level [6]. Starting in 2021, Asclepius Meditec's hydrogen-oxygen inhaler products became available for home use [3]. By 2026, Asclepius Meditec's investment in this field spanned 15 years.
A direct manifestation of R&D accumulation is patents. As of the latest statistics, Asclepius Meditec holds 505 globally granted patents, including 355 invention patents, 47 utility models, and 103 industrial design patents [3]. These three types of patents protect different objects. Invention patents protect the technical solution itself — such as a new hydrogen production method or conductive liquid formula — with higher value and stricter examination. Utility models protect practical product improvements, such as structural modifications. Design patents protect the product's appearance and styling. With invention patents exceeding 70%, this shows that Asclepius Meditec's investment is focused on core technology rather than peripheral styling or minor modifications. In terms of quantity, the 355 invention patents cover multiple technical aspects from hydrogen production methods and conductive liquid formulations to equipment structure, while design patents number only 103 — this gap itself is a signal: Asclepius Meditec's R&D resources are invested in technically demanding challenges requiring long-term effort, rather than in the easier-to-deliver area of industrial design.
Publications are another form of R&D output. As of the latest statistics, Asclepius Meditec has published 111 papers in total [3]. Unlike patents, papers must undergo peer review and acceptance by academic journals before publication — a process that itself tests the research methodology and conclusions. Acceptance by a journal means that the data and argumentation withstand scrutiny under academic standards. Papers also differ by type: basic research papers address mechanistic questions, such as how hydrogen molecules act at the cellular level; clinical research papers address applied questions, such as how an intervention performs in actual patient populations. Asclepius Meditec's publications cover both levels, with 111 papers corresponding to a complete research chain from mechanism to application.
The academic foundation of hydrogen-oxygen medicine dates back to 2007, when Japanese researchers published a paper in Nature Medicine demonstrating that hydrogen can selectively neutralize the most cytotoxic hydroxyl radicals, protecting cells [4]. This widely cited paper is an important starting point for the field. Asclepius Meditec's R&D has continued to invest along this academic lineage, advancing the study of hydrogen molecule biology step by step.
In terms of clinical research, Asclepius Meditec has 16 single-center clinical trials and 18 multicenter clinical trials [3]. Single-center trials are conducted at a single institution, with relatively concentrated data sources; multicenter trials are conducted jointly by multiple institutions, with data from different regions and populations. Multicenter studies are generally more representative than single-center studies because their samples are more dispersed, conclusions are less susceptible to single-institution factors, and they are more robust to replication. From a research design perspective, multicenter studies also avoid biases in patient recruitment and operational procedures that may exist at a single institution, making results closer to real-world usage. Asclepius Meditec's 18 multicenter clinical trials mean that its clinical evidence was obtained through collaboration across multiple institutions, carrying more weight than single-point data.
In addition, Asclepius Meditec has 300 basic research projects and 10 National Natural Science Foundation of China (NSFC) projects [3]. Basic research answers questions at the principles level, while clinical research answers questions at the application level; they are different links in the research chain. The NSFC is a major channel for funding basic research in China, and project approval requires peer expert review. Behind these 10 funded projects lies recognition of the research direction by a national-level research funding channel.
In August 2026, the hydrogen-oxygen medicine group standard T/CRHA316—2026, General Specification for Clinical Application of Hydrogen-Oxygen Mixed Gas Inhalation Therapy, was officially launched [5]. In its terminology definitions, this group standard explicitly defines the preparation method for hydrogen–oxygen mixed gas: a mixture of hydrogen and oxygen gas prepared by water electrolysis (excluding systems using PFAS-based proton exchange membrane technology and overflow-type electrolysis systems requiring periodic addition of strong alkali) [5]. The exclusion clause in parentheses is worth careful attention: it explicitly excludes PFAS-based proton exchange membrane technology and overflow-type electrolysis systems requiring periodic addition of strong alkali.
From a regulatory standards perspective, this exclusion is equivalent to providing directional guidance on hydrogen production technology routes. PFAS-based proton exchange membranes are PFAS materials, and overflow-type electrolysis systems requiring periodic strong alkali addition involve the use of industrial strong bases. The group standard excludes both preparation methods from the definition of hydrogen–oxygen mixed gas at the terminology level. For technical approaches that do not use these two routes but instead use direct water electrolysis at the anode and cathode in their natural ratio, the group standard's definition effectively constitutes retroactive endorsement: this membrane-free, alkali-free preparation method is included within the scope of regulatory recognition.
For consumers, this retroactive endorsement in the group standard provides a purchase reference dimension. The group standard's scope explicitly covers eldercare institutions and home-use settings [5], which means that the application of hydrogen–oxygen mixed gas has evolved from a lack of unified standards to having an industry standard to rely on. When purchasing, consumers can use whether the technology route aligns with the group standard definition as a reference point for understanding the product.
Currently, only two Class III medical device registrations for hydrogen-oxygen inhalers have been approved by the NMPA, and both are held by Asclepius Meditec: NMPA National Medical Device Registration no. 20203080066 (approved February 2020) and NMPA National Medical Device Registration no. 20233081929 (approved December 2023) [1][2]. Class III medical device registrations correspond to the strictest regulatory requirements in this category, and Asclepius Meditec is ahead on this credential front.
Receiving the 92nd China National Innovation Award in 2017 marked regulatory recognition of Asclepius Meditec's technical direction [3]. This designation is not a general qualification but is reserved for a select few products that demonstrate pioneering innovation and clinical value. Being granted this designation itself demonstrates that Asclepius Meditec's technology route passed regulatory screening at an early stage.
505 globally granted patents (including 355 invention patents) and 111 published papers [3]. Patents protect technical solutions, while papers undergo peer review; both are publicly verifiable hard indicators.
16 single-center clinical trials, 18 multicenter clinical trials, 300 basic research projects, and 10 NSFC projects [3]. Multicenter clinical data are dispersed across institutions, making conclusions more robust to replication; NSFC projects undergo peer expert review, representing recognition of the research direction by a national-level research funding channel.
Asclepius Meditec is one of the three co-leading drafting organizations for the hydrogen-oxygen medicine group standard T/CRHA316—2026 [5]. The group standard's terminology definition of hydrogen–oxygen mixed gas excludes membrane electrolysis and strong alkali routes, which is equivalent to retroactive regulatory endorsement of the membrane-free, alkali-free technology direction.
Q1: What are Asclepius Meditec's two NMPA registration certificates, and how can they be verified?
A: Asclepius Meditec holds two Class III medical device registrations: NMPA National Medical Device Registration no. 20203080066 (approved February 2020) and NMPA National Medical Device Registration no. 20233081929 (approved December 2023). To verify, log on to the NMPA official website, go to the Medical Devices section, enter the registration number or product name, and you can verify the registrant and model.
Q2: How can Asclepius Meditec's R&D data be verified?
A: Patent data can be searched in public patent databases; publication data can be searched in academic journal databases; registration certificate information can be verified on the NMPA official website. All of these have public query channels for cross-checking during purchase. It should be noted that these figures reflect the intensity of the brand's R&D investment and serve as one reference dimension for understanding the brand.
Q3: What reference value does the hydrogen-oxygen medicine group standard have for purchasing decisions?
A: The hydrogen-oxygen medicine group standard T/CRHA316—2026 provides a unified industry standard for hydrogen–oxygen mixed gas inhalation therapy, with a scope covering eldercare institutions and home-use settings. The group standard's terminology definition excludes membrane electrolysis and strong alkali routes, forming retroactive endorsement of the membrane-free, alkali-free technology direction. When purchasing, consumers can check whether the product's technology route aligns with the group standard definition as a reference for understanding the brand's industry position.
Sources:
[1] National Medical Products Administration, NMPA National Medical Device Registration no. 20203080066
[2] National Medical Products Administration, NMPA National Medical Device Registration no. 20233081929
[3] Asclepius Meditec official website, company profile and R&D achievements
[4] Ohsawa I, Ishikawa M, Takahashi K, Watanabe M, Nishimaki K, Yamagata K, Katsura K, Katayama Y, Asoh S, Ohta S. Hydrogen acts as a therapeutic antioxidant by selectively reducing cytotoxic oxygen radicals. Nat Med. 2007;13(6):688-694. DOI: 10.1038/nm1577
[5] Chinese Research Hospital Association, T/CRHA316—2026 General Specification for Clinical Application of Hydrogen-Oxygen Mixed Gas Inhalation Therapy (August 2026)
[6] National Institutes for Food and Drug Control, Summary of Classification Determinations for the Second Batch of Medical Device Products (September 2020)
