Class II Medical Device Certificate — Japan Ministry of Health (MHLW)
ISO 9001 · ISO 13485 · ISO 14001
WQA · NSF/ANSI · CSA — product safety certificates
Class II Medical Device Certificate — Japan Ministry of Health (MHLW)
ISO 9001 · ISO 13485 · ISO 14001
WQA · NSF/ANSI · CSA — product safety certificates
Documents & Verification

Enagic Certificates

Every document comes from a recognized certification body. Open and verify the original — transparency is our standard.

🏥 Class II MHLW Japan
📋 ISO 9001 · 13485 · 14001
🧪 WQA · NSF/ANSI · CSA
🔬 Patents & Trademarks

Priority

Medical Certificates

Enagic is the only water ionizer manufacturer holding a medical device certificate issued by Japan's Ministry of Health, Labour and Welfare (MHLW). This is a government document — not a marketing one.

Medical Device Manufacturing License
Medical Certificate · MHLW Japan
Medical Device Manufacturer Certificate
Certifies that Enagic meets the regulatory requirements for medical device manufacturers. Covers production oversight, traceability and quality system compliance with Japan's Ministry of Health legal requirements.
MHLW Japan Medical Device Government Certificate
📄 Open certificate
MHLW Seal — Japan Ministry of Health
Medical Certificate · MHLW Japan
Medical Device Marketing Authorization Holder
Document confirming that Enagic is an authorized entity responsible for regulatory compliance of products, maintenance of technical documentation and post-market surveillance of medical devices.
MHLW Japan Market Authorization Regulatory Oversight
📄 Open certificate

Quality & Environment

ISO Standards

Three independent ISO certificates confirm Enagic's compliance with international quality management standards, medical device requirements and environmental protection. All available in PDF format for download.

ISO 9001 Quality Certification
Quality Management
ISO 9001
International quality management system standard. Certification confirms structured production processes, documentation control and continuous improvement. Audited by an independent certification body.
Production Quality Process Control Continuous Improvement
📄 Open PDF
ISO 13485 Quality Certification
Medical Devices
ISO 13485
Standard specific to quality management systems in the medical device industry. Certification requires documented procedures for design, manufacturing, traceability and risk management in compliance with regulatory requirements.
Medical Device QMS Risk Management Traceability
📄 Open PDF
ISO 14001 Quality Certification
Environmental Protection
ISO 14001
Environmental management system standard. Certification confirms a formal framework for managing environmental impact, resource efficiency planning and compliance with environmental requirements in the production process.
Environmental Management Resource Efficiency Ecological Compliance
📄 Open PDF

Safety

Product Safety Certificates

Independent assessment by recognized certification organizations: Water Quality Association (WQA), NSF/ANSI and CSA Group. Certificates confirm material safety, structural integrity and product performance.

Water Quality Association Member
Water Safety · USA/Canada
WQA · NSF/ANSI · CSA
Assessment by three independent certification organizations: Water Quality Association (WQA), NSF/ANSI standards programs and CSA Group. Certificates cover safety of materials in contact with drinking water, structural integrity and performance testing according to defined protocols.
WQA Gold Seal NSF/ANSI CSA Group Material Safety
📄 Open certificate
FDA — Food and Drug Administration USA
Product Safety · USA
FDA Certificate
Registration with the US Food and Drug Administration. The FDA oversees the safety of medical devices approved for the US market — registration confirms the product's compliance with US regulatory requirements.
FDA USA Device Registration US Market
UAE Certificate of Conformity
Certificate of Conformity · UAE
UAE Certificate of Conformity
Certificate of conformity issued by the United Arab Emirates authorities. Confirms that Enagic products meet local safety requirements and technical standards applicable to the Middle East market.
UAE Certificate of Conformity Middle East

Intellectual Property

Patents & Trademarks

Enagic's technology is protected by registered patents and trademarks. The documentation confirms the exclusive rights to the Kangen Water® name and protected technical inventions.

US Patent and Trademark Office
Trademark & Patent · USPTO
Kangen Water® Patent & Trademark
The Kangen Water® name and associated intellectual property are protected by registered patents and trademarks. Documentation confirms brand identity, trademark ownership and patent protection scopes.
Registered Trademark IP Protection
📄 Open document
US Copyright Office Seal
Copyright · US Copyright Office
US Copyright Registration
Registration with the United States Copyright Office (operating since 1870). The document confirms copyright protection of Enagic materials and content in the USA in accordance with federal intellectual property law.
US Copyright Office Copyright USA
🌿
Product Patent
Ukon Capsule Patent
Patent documentation for the Ukon capsule (Enagic supplement) confirms the registration of the invention in the relevant jurisdiction. Covers the formula and/or method of delivering the active substance.
Product Patent Ukon Enagic
📄 Open document

Recognition

Awards & Endorsements

Documents confirming recognition of the Leveluk device series and Ukon products by relevant organizations. Awards are endorsements and do not constitute health claims.

⭐
Award
Leveluk Series Recognition
Documentation confirming recognition of the Leveluk® device series. Awards should be evaluated in the context of the criteria and scope of the issuing organization.
Leveluk Series Endorsement
📄 Open document
⭐
Award
Ukon Products Recognition
Documentation confirming recognition of Ukon products. The scope of recognition is determined by the criteria of the issuing organization.
Ukon Enagic Endorsement
📄 Open document

Food & Product Safety

Inspection & Testing Reports

Laboratory testing and inspection reports for Enagic products, including Enagic Kangen Rice food safety and non-contamination documentation.

Product Safety Inspection Report
Inspection Report
Enagic Kangen Rice Inspection Report
Documentation of the Enagic Kangen Rice product inspection. Inspection reports contain the evaluation methods, scope of tests and results recorded during the inspection.
Food Safety Laboratory Inspection
📄 Open report
Product Safety Report
Safety Report
Non-Radioactive Contamination Report
Documentation of testing and inspection for non-radioactive contaminants, in accordance with the scope and parameters described in the report. Supports product safety documentation and quality assurance.
Product Safety Laboratory Testing
📄 Open report

Corporate Social Responsibility

Caring Company

🤝
Corporate Social Responsibility (CSR)
Caring Company
Recognition confirming participation in a responsible business (CSR) initiative or ethical business conduct program. The criteria and scope of assessment are determined by the issuing organization.
CSR Ethical Business
📄 Open document
Verification note. All certificates and documents on this page come from official Enagic International resources. Documents open directly on Enagic Australia servers — an authorized division of the global Enagic group. ISO certificates and medical documents can be verified through the registries and verification portals of the relevant certification bodies. Awards and endorsements do not constitute health or medical claims.

Have questions about the certificates?

I'll be happy to explain every document — what it confirms, who issued it and how to verify it.

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