For medical device development, please contact us first.
We are working with the dream of contributing to the medical field around the world. Our company is licensed for the manufacturing and sales of medical devices, and we engage in contract development of medical devices using the experience and technical skills we have cultivated over many years. We also handle the development, certification, and manufacturing of medical devices that comply with overseas standards such as the CE mark (Europe) and CCC mark (China). Currently, we are involved in the manufacturing and sales of products such as artificial dialysis machines, infusion pumps, and auxiliary artificial heart drive devices. We are also applying for regulatory approval and are committed to development and manufacturing. We can assist you with medical device development. If you are considering new medical device development, please feel free to reach out to us.
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basic information
○Medical Device Development Services ・Development, manufacturing, and sales of medical devices ・Pharmaceutical approval applications ・Development and manufacturing of medical devices compliant with international standards ・Acquisition of certifications compliant with international standards Type I Medical Device Manufacturing and Sales Business License
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Applications/Examples of results
○Achievements (1) Dialysis machine (2) Infusion pump (3) Ventricular assist device (4) RO water production system (5) Hand washing cleaning device (UF filter system) (6) Other approved medical devices and medical devices for overseas use
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Company information
Our company manufactures and sells mechatronic products, medical products, electronic devices, and electronic components. YAEI SII ELEX is on a path as a proposal-based company, merging rich creativity with advanced technology. YAEI SII ELEX provides products utilizing cutting-edge electronics technology.