[Example of Certification for Medical Devices for In Vitro Diagnostics under European Regulations] Fujifilm Corporation
Introducing the case of the in vitro diagnostic reagent "DRI CHEM SLIDE" obtaining IVDR certification!
We would like to introduce a case of obtaining the "In Vitro Diagnostic Medical Devices Regulation (IVDR)" for Fujifilm Corporation. The company's in vitro diagnostic reagent "DRI CHEM SLIDE" has obtained IVDR certification. This certification was issued for the in vitro diagnostic medical device intended for Near Patient Testing (NPT). 【Case Overview】 ■ Obtaining IVDR certification *For more details, please download the PDF or feel free to contact us.
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TÜV SÜD is one of the world's largest third-party testing and certification organizations headquartered in Germany, providing certification, inspection, testing, and evaluation services across a wide range of fields. The company's Japanese subsidiary, TÜV SÜD Japan, was established in 1993 to respond to the growing demand for quality and safety testing and certification in the Japanese market under TÜV SÜD's business framework. It offers various testing, certification, auditing, management system certification, and training services in a wide range of fields, including electrical and electronic equipment, healthcare and medical devices, industrial equipment, IT and AV equipment, 5G-related devices, food, automotive, railways, energy and plant equipment, chemicals and processes, and cosmetics.