TOKYO, Japan, Sept. 6, 2019 /PRNewswire/ — DEKRA issued CE certificate to Sanyo Chemical Industries (Kyoto, Japan) for their innovative surgical sealant. Sanyo Chemical is a mission-oriented company, always making unprecedented challenges. Their cardiovascular hemostatic sealant certified by DEKRA is classified as highest risk device which is subject to the most stringent scrutiny. This certification marks their first achievement in Europe.
Takao Ando, President CEO at Sanyo Chemical said "Without DEKRA’s hard work, we could never make this happen. Their effort to bring only patient-first products is admirable. DEKRA Japan provided timely assistance which was most appreciated."
DEKRA has rich professional knowledge and experience in the Medical field and is one of the five largest Notified Bodies in the world.
DEKRA has already obtained Notified Body (NB) designation for European Medical Devices Regulation (MDR), the NB number of DEKRA Certification GmbH is 0124. Additionally it is expected to obtain MDR accreditation as well for DEKRA Certification B.V in Netherlands with Notified Body number 0344.
With a global network of offices and state-of-the-art laboratories, DEKRA can also help medical manufactures to gain worldwide access to markets including Europe, Taiwan, the USA, Canada, Brazil, Australia and Japan. In addition, DEKRA can provide certification support for quality management systems in combination with CE certification.
About Sanyo Chemical
Sanyo Chemical is a manufacture of performance chemicals, established in 1949 in Kyoto, Japan. Performance chemicals featured by functional characteristics are made to respond to various costumer needs such as safer, more beautiful, more comfortable and environment friendlier. They started as a manufacturer of soap and textile agents, and diversified their product line to satisfy the needs of the market. The company operates in six business segments: toiletries & health, petroleum & automotive, plastic, textiles, info/electronic & construction/others. Their solutions are essential to people’s daily lives from automotive to daily electronics, passing by cosmetics and medical equipment. Now they have over 3,000 different types of products. Sanyo endeavors to create better life and society through performance chemicals in various fields.
DEKRA has been active in the field of safety for more than 90 years. Founded in 1925 in Berlin as Deutscher Kraftfahrzeug-Uberwachungs-Verein e.V., it is today one of the world’s leading expert organizations. DEKRA generated revenues totaling more than EUR3.3 billion in 2018. The company currently employs more than 45,000 people in around 60 countries on all six continents. With qualified and independent expert services, they work for safety on the road, at work and at home. These services include vehicle inspection, claims & expertise, product testing, industrial inspection, audits, consulting, training and temporary work. The vision for the company’s 100th birthday in 2025 is that DEKRA will be the global partner for a safe world.
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