Certification for "designated management medical devices (19 categories)" and "designated in vitro diagnostic drugs" is possible!
Our company provides "Medical Device Certification Services" as a certification body registered with the Ministry of Health, Labour and Welfare for designated management medical devices and designated in vitro diagnostic drugs. We mainly handle items such as anesthesia and respiratory devices, dental equipment, and medical electrical equipment. Please feel free to contact us first. 【Features】 ■ Highly specialized and experienced staff conduct the reviews ■ Rapid and reliable certification through our unique certification management system (Expedited service consultations are also available) ■ Provision of appropriate certification costs and clear services for customers ■ Capable of conducting electrical safety tests, EMC tests, wireless tests, and biocompatibility tests ■ Initial free consultations available upon request *For more details, please download the PDF or feel free to contact us.
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【Designated Managed Medical Devices and Designated In Vitro Diagnostic Drugs】 ■ Anesthesia and Respiratory Equipment ■ Dental Equipment ■ Medical Electrical Equipment ■ Facility Equipment ■ Ophthalmic and Visual Equipment ■ Renewable Equipment ■ Single-use Equipment ■ Hearing Aids ■ Home Massage Devices, Home Electrical Therapy Devices, and Related Equipment ■ Radiation and Imaging Diagnostic Equipment ■ In Vitro Diagnostic Drugs *For more details, please download the PDF or feel free to contact us.
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For more details, please download the PDF or feel free to contact us.
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Company information
Our company provides technical support for CE marking to Japanese equipment manufacturers based on the technology and knowledge cultivated from a German semiconductor manufacturing equipment manufacturer, assisting in exports to Europe. Additionally, through training from European certification bodies, we have expanded our operations to include safety evaluations of products in various fields, and we continue to operate as a registered medical device and in vitro diagnostic product certification body with the Ministry of Health, Labour and Welfare, as well as a confirmation review body for certified testing reagents.