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Press release

DEKRA certifies innovative Japanese surgical sealant made by Sanyo Chemical

5. Sep 2019

DEKRA issued CE certificate to Sanyo Chemical Industries for their innovative surgical sealant.

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.

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