The World’s First Hydrogen-Oxygen Nebulizer to Receive Class III Medical Certification

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DuPont Statement
The Manufacturer's Own Warning: What Their Disclaimer Means for You
The use of industrial-grade ion-exchange membranes with toxicological risks is strictly prohibited in human medical applications.
Foxconn Production
Explosion-proof Detection Video
hydrogen-oxygen Atomizer
400 Safety Inspections
Global Patent
True and False Comparison

Ion Membrane Supplier's Disclaimer

Background Information (Legal Action)
Due to the potential for harm caused by toxic industrial-use perfluorinated compounds (PFAS), there have been multiple international medical lawsuits with total compensation claims potentially exceeding $10 billion.
During the COVID-19 pandemic, some appliance manufacturers—whether informed or not—incorporated this potentially harmful and toxic material into a core component of their devices: the water electrolysis cell.
In line with their corporate social responsibility and ethical obligations, a major international company has issued this disclaimer to urge all parties to prioritize and protect the health and safety of consumers.

Asclepius’ Innovation vs. Market Disorder
In the early stages of the COVID-19 pandemic in 2020, there was a global shortage of ventilators and oxygen generators. It was at this critical time that the Asclepius Hydrogen-Oxygen Mixed Gas Generator, a Class III medical device with a decade of unique water electrolysis technology designed for human safety, was approved by the China National Medical Products Administration (NMPA) to treat COVID-19 patients.

The massive market demand quickly led to manufacturers of industrial-grade hydrogen equipment—such as those used for hydrogen energy, combustion engines, metal welding, and automotive decarbonization—to start producing imitation medical devices for human inhalation. These products have not undergone the rigorous testing required for Class III medical devices and have already led to various reported adverse events in different countries.

Disclaimer from a Leading International Chemical Company
In response to these market irregularities, a major global chemical company has issued a formal disclaimer:

"Do not use PFSA membranes (including N-112, 115, 117, NE-1135, 1110 perfluorosulfonic acid polymer) in medical applications involving implantation in the human body or contact with internal body fluids or tissues. "

Notable Incidents

  1. Japan Case (March 2021)

According to a report by the Japanese newspaper Asahi Shimbun, an employee at a cosmetics company in Tokyo was involved in a fatal accident while attempting to replicate a hydrogen-oxygen device. The incident resulted in an explosion, causing one death and one severe injury.

  1. China Case (March 2023)

In Changsha, Hunan, China, an elderly patient died of an unknown cause after using a hydrogen-oxygen machine that had not been approved for market release by China's National Medical Products Administration (NMPA).

The Manufacturer's Own Warning: What Their Disclaimer Means for You

The Manufacturer's Own Warning: What Their Disclaimer Means for You

DO NOT USE OUR MATERIALS IN MEDICAL APPLICATIONS INVOLVING IMPLANTATION IN THE HUMAN BODY OR CONTACT WITH INTERNAL BODY FLUIDS OR TISSUES UNLESS THE MATERIAL HAS BEEN PROVIDED FROM US UNDER A WRITTEN CONTRACT THAT IS CONSISTENT WITH THE OUR POLICY REGARDING MEDICAL APPLICATIONS AND EXPRESSLY ACKNOWLEDGES THE CONTEMPLATED USE.
MAKES NO REPRESENTATION, PROMISE, EXPRESS WARRANTY OR IMPLIED WARRANTY CONCERNING THE SUITABILITY OF THESE MATERIALS FOR USE IN IMPLANTATION IN THE HUMAN BODY OR IN CONTACT WITH INTERNAL BODY FLUIDS OR TISSUES.
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The use of industrial-grade ion-exchange membranes with toxicological risks is strictly prohibited in human medical applications.

The use of industrial-grade ion-exchange membranes with toxicological risks is strictly prohibited in human medical applications.

DO NOT USE IN MEDICAL APPLICATIONS INVOLVING PERMANENT IMPLANTATION IN THE HUMAN BODY.
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Foxconn Production

Foxconn, a world-renowned contract manufacturing enterprise, is internationally recognized for its advanced capabilities in precision component production and product assembly.

Currently, Foxconn holds ISO 13485 medical device certification and operates cleanroom facilities that meet the stringent requirements for medical device manufacturing. Leveraging its automated “lights-out” assembly and testing lines, Foxconn ensures high-efficiency mass production while maintaining the quality standards required for Class III medical devices. This includes the hydrogen-oxygen nebulizers developed by Asclepius Meditec.

With more than 100 factories across the globe, Foxconn provides robust infrastructure and scalable capacity to support the global distribution and after-sales service of Asclepius Meditec’s hydrogen-oxygen nebulizers, enabling the company to meet growing international demand.

AMS-H-03

Class III medical devices
Price: $18000.00
Main features:
  • Registration Number: NMPA 20203080066
  • Flow Rate Settings: Adjustable in three increments — 2.0 L/min, 2.5 L/min, and 3.0 L/min
  • Dimensions (mm): 470*240*490
  • Clinical settings: hospitals, outpatient clinics, rehabilitation centers
    Long-term care facilities: nursing homes, assisted living
    Retail and community: pharmacies, health clubs, wellness centers

AMS-H-01

Class III medical devices
Price: $27000.00
Main features:
  • National Machinery Registration No: 2020 3080066
  • Gas production gear/adjustment mode: Third gear(2L, 2.5L, 3 L touch adjustment)
  • Size (mm): 450*245*485
  • Application: Respiratory department, sleep department, geriatrics department, etc.

AMS-H-03/30C

Class III medical devices
Price: $16000.00
Main features:
  • National Machinery Registration No: 20233081929
  • Gas production gear/adjustment mode: Third gear (2L, 2.5L, 3L voice adjustment)
  • Size (mm): 285*285*385
  • Application: Drugstore, clinic, health club, family, medical beauty center, senior center, gym. 

Comprehensive 400-Point Safety Inspection Protocol

These are the key safety evaluation criteria applied to hydrogen-oxygen nebulizers (inhalation therapy devices), in compliance with international medical device safety and engineering standards.

Gas Leakage Detection

Inspect the entire gas delivery system—including pipelines, joints, and connectors—for potential hydrogen (H₂) and oxygen (O₂) leaks using certified detection methods such as hydrogen gas sensors or the soap bubble test. Ensure zero risk of combustible gas accumulation.

Gas Concentration Monitoring

Verify that the hydrogen-to-oxygen ratio remains within medically approved thresholds (typically 66.7% H₂ and 33.3% O₂ by volume) using continuous gas concentration monitoring systems. This ensures therapeutic safety and device compliance.

Electrical Safety Inspection

Conduct thorough electrical safety testing to confirm proper grounding, insulation integrity, and short-circuit protection. Examine all power cords, plugs, and internal circuitry for damage, overheating, or signs of degradation.

Sterilization and Hygiene Compliance

Ensure all patient-contact components (e.g., nasal cannula, tubing, and water reservoirs) undergo validated disinfection processes. Confirm that disposable parts are replaced on schedule in accordance with medical sterilization guidelines to prevent microbial contamination.

Flame and Explosion Prevention

Ensure no open flames or sparks near the device (hydrogen is highly flammable). Check if anti-static measures are in place for pipelines and components.
Request Inspection Standards

Global Patent Protection

The hydrogen-oxygen nebulizer is protected by a comprehensive portfolio of international patents. This includes invention patents covering its advanced gas-mixing system, ultra-fine atomization technology, and integrated safety mechanisms. Global PCT filings ensure broad international intellectual property coverage, while utility model patents cover its streamlined design and integrated noise-reduction features.

In addition, proprietary software algorithms, secured through encryption, support precise flow calibration and continuous real-time monitoring, reinforcing both device performance and operational safety.
Request Patent Details
459 Global Patents
Key figures as of August 2025

315

Inventions

98

Design

46

Utility model

Asclepius Hydrogen-Oxygen Nebulizers VS Industrial Hydrogen Generator

Asclepius Meditec VS Industrial PEM/SPE Electrolyzers
Certified Class III Medical Device by NMPA (CFDA) Certification Industrial safety certifications only (e.g., CE, UL); not certified for medical use
Complies with Chinese Class III medical device standards Regulatory Standard Follows general electrical/electronic industrial standards
Complies with ISO and EMC safety standards; clean production environment; uses certified medical-grade materials Manufacturing Process Uses non-compliant materials; lacks quality control; unauthorized/illegal production practices
Passed biocompatibility and toxicology tests using approved medical materials Material Safety Uses non-medical, industrial-grade materials; contains hazardous or potentially carcinogenic substances
Meets medical safety requirements; sterilization-validated; biocompatible Safety Standards Meets only industrial manufacturing standards or unregulated
Designed for therapeutic use in clinical settings (human inhalation therapy) Primary Application Originally developed for industrial hydrogen energy applications
Controlled H₂-O₂ mixture (66% H₂, 33% O₂) for medical therapy Gas Output Composition Delivers high-purity hydrogen ( 99.97%), not optimized for medical inhalation
Does not require to regularly add industrial-grade alkaline electrolyte Electrolysis Technology Uses high-efficiency solid PEM/SPE membranes; may contain toxic fluorinated compounds
Conforms to the tidal volume necessary for human respiration Flow Rate Usually small
Validated through extensive human clinical trials and medical studies Clinical Validation No clinical validation for therapeutic use
Hospitals, clinics, home healthcare, and medical practices End-User Setting Energy production plants, laboratories, industrial applications

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