06 September 2019 | News
This certification marks their first achievement in Europe
DEKRA, a European vehicle inspection , has CE certificate to Japan headquartered Sanyo Chemical Industries 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.