Why can a medical device containing two flammable gases, hydrogen and oxygen, obtain NMPA approval for household use? What core technologies support the Asclepius hydrogen-oxygen generator, and how does it surpass traditional industrial water electrolysis methods to achieve dual breakthroughs in safety and efficacy? This article provide an in-depth analysis of the technical secrets behind China’s first Class III active hydrogen medical device approved for home use, covering three key areas technical routes, material safety and clinical verification. It is intended for consumers comparing hydrogen-oxygen products, medical equipment purchasers and technology enthusiasts.
Commercially available hydrogen-oxygen machines appear similar in principle, yet a significant regulatory gap exists between industrial electrolysis technology and medical-grade technology.
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Dimension |
Traditional Industrial Technology (AEC / PEM) |
Asclepius State-Certified Innovative Technology |
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Technical Route |
Industrial-grade Alkaline Electrolysis Cell (AEC) requiring potassium hydroxide (KOH) alkali powder, or Proton Exchange Membrane (PEM) with perfluorinated compound membranes |
Overcomes two major technical barriers of AEC conductive liquid electrolysis and PEM ion membrane electrolysis, delivering a medical-grade electrolysis solution with "no membranes, no alkali additives", and ensuring material safety from the source |
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Material Safety |
PEM membranes contain perfluorinated substances; long-term exposure to such chemicals has sparked extensive academic discussions and legislative concerns over health risks. Inhalation of strong alkaline solutions causes definite chemical irritation, with no biocompatibility testing conducted |
Biocompatibility assessments including cytotoxicity, intradermal reactivity and sensitization tests were performed on nasal masks in direct patient contact and gas flow channels with indirect contact, complying with the latest edition of ISO 10993 (GB/T 16886). The conclusion confirms acceptable biocompatibility risks |
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Legal Compliance Basis |
Implements industrial GB/T standards without NMPA medical device registration certificates; prohibited for human inhalation |
Holds two NMPA Class III medical device registration certificates: NMPA 20203080066 and NMPA 20233081929 |
Asclepius Meditec has built the world’s most extensive patent portfolio centered on hydrogen-oxygen generator technologies.
Safety is the top priority for any device intended for human inhalation, especially hydrogen-oxygen equipment.
At the 5th International Congress of Hydrogen Medicine and Biology, Shanghai Asclepius Meditec Co., Ltd. was honored the Industrial Breakthrough Award by the International Society for Hydrogen Medicine and Biology (ISHMB).
The honor recognizes its groundbreaking achievements in securing the world’s first medical device approval for hydrogen-oxygen generators and advancing their clinical application. The award was presented by Professor Shigeo Ohta, the preeminent global authority on hydrogen medicine, signifying high-level international academic recognition for China’s indigenous hydrogen-oxygen medical innovations.
From original technological breakthroughs and rigorous material safety control to leading global patent volume and authoritative international accreditation, the Asclepius hydrogen-oxygen generator represents a landmark indigenous translational success in China’s hydrogen-oxygen medical industry, as well as an emblem of high-end Chinese medical devices expanding to global markets.
Built on the state-certified innovative "no membranes, no alkali" water electrolysis technology, the Asclepius hydrogen-oxygen generator holds 494 global patents and full Class III medical device registration. In 2023, It received NMPA approval for household use, ranking among the world’s hydrogen-oxygen products with the broadest patent coverage and most complete evidence-based clinical chain.
A: It adopts the state-certified patented biological electrolyte recycling technology featuring "no membranes, no alkali additives", which differs fundamentally from industrial AEC (requiring strong alkali) and PEM (containing perfluorinated membranes) technologies and eliminates hazardous material risks at the source.
A: As of May 2026, 494 global patents have been granted (344 invention patents, 103 design patents, 47 utility model patents), with 606 total applications filed. The company owns the largest patent portfolio globally in hydrogen-oxygen medicine.
A: It features a zero-gas-chamber structural design, multiple physical flame arrestors and built-in hydrogen concentration sensors. Under extreme simulated ignition tests, only low-volume bangs below 80 decibels occur without bodily injury, fully complying with Class III medical device safety specifications.
A: Yes. In December 2023, the company obtained its second Class III registration certificate (NMPA 20233081929), expanding the intended use scope from "institutional use only" to "usable in medical institutions and home care environments". It is China’s first Class III active hydrogen medical device legally approved for household deployment.
