TAGS: Sealants
Sanyo Chemical Industries has announced its certification of CE marking of cardiovascular hemostatic sealant, its brand name AQUABRID® in Europe by DEKRA. Its cardiovascular hemostatic sealant certified by DEKRA is classified as highest risk devices which are subject to most stringent scrutiny. This certification marks Sanyo’s first achievement in their European business.
Only Patient-first Products to the Market
AQUABRID® is surgical hemostatic agent which is used for
anastomosing the arterial blood and artificial blood vessel in the surgical operation. This product is polyurethane prepolymer made by non-biological materials. And it has high hemostatic property independent on the patient's blood coagulation ability and enables to form curing film having the flexibility.
Since October in 2019, Sanyo Chemical will distribute AQUABRID® in corporation with Terumo Europe NV. Takao Ando, President CEO at Sanyo Chemical said “
Without DEKRA’s hard work, we can never make this happen. Their effort to bring only patient-first product is admirable. DEKRA Japan provided timely assistance which was most appreciated for us”.
DEKRA: One of the Five Largest Notified Bodies
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), 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.
Source: Sanyo Chemical