As an ISO 13485:2016 and CE certified high-tech-enterprise, Huizhou Kaiyi Technology Co., Ltd.( hereinafter referred to as " Kaiyi ") has been deeply committed to the research, development,manufacturing, marketing, and after-sales service of respiratory healthcare solutions since its establishment in 2015.
In 2023, the company's products successfully obtained FDA certification in the United States,signifying their compliance with stringent international standards. Subsequently, in 2024,the products achieved BSCI certification, further demonstrating Kaiyi's dedication to ethical and sustainable business practices.
Welcome to cooperate with Kaiyi for mutual benefit and sustainable development
With over a decade of specialization in R&D and production of respiratory products, our core team possesses profound expertise. We operate a 10000+ ㎡ owned factory with 100,000-class whiteroom, certified to ISO 13485 and CE certification, committed to delivering integrated innovative solutions from development to delivery.
Local compliance met, smooth customs clearance
Stable supply chain and guaranteed delivery
Own factory, stable capacity, customization supported
The core team has over 10 years of experience in R&D and production of respiratory products, ensuring a deep understanding of market needs.
High-Standard Owned Factory
Operates a 10000+ ㎡ factory with 100,000-class whiteroom and ISO 13485 certification, guaranteeing production quality.
International Market Access
Holds CE and FDA certification and maintains a full-process quality system, providing a solid foundation for global expansion.
Driven by Continuous Innovation
Committed to R&D in new technologies and materials, enhancing product value with innovative solutions.
Global Cooperation
With CE, FDA, BSCI, and ISO13485 certifications, we serve over 80 countries and regions worldwide – providing trusted respiratory health solutions to both medical institutions and families. We actively seek long‑term partnerships with distributors, healthcare providers, and research organizations to expand access to qualified respiratory care. Join us in shaping global respiratory health.
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