SHENZHEN, China, Dec. 12, 2023 -- Edan Instruments, Inc.(300206) recently announced that its i15 Series blood gas and chemistry analyzer was granted the Class C certificate under the In Vitro Diagnostics Regulation (IVDR) by TÜV SÜD, a notified body designated under the European Union (EU)'s IVDR. EDAN has achieved a significant milestone as one of the first medical device manufacturers in China with the EU IVDR CE certification.
Moreover, EDAN's IVD product line have also received the IVDR Certificate, encompassing the comprehensive range of products offered by the company, including its 5-part and 3-part hematology analyzer, H60 Series and H30 Pro. This achievement underscores EDAN's dedication to maintaining excellence across its entire IVD product portfolio, showcasing a commitment to quality and regulatory compliance.
CE certification is a pass for product to enter the European market and circulate freely throughout the EU. It represents that the products comply with the relevant EU laws, regulations and standards. Compared with the previous IVDD, the newly launched IVDR aims to establish a modern and stricter regulatory framework to better protect the health and safety of the public and patients. The strict evaluation standards and approval process have discouraged many companies, making it one of Europe's most demanding medical device regulations.
The most recent IVDR categorizes in-vitro diagnostic (IVD) devices into four risk-based classes: A, B, C, and D. EDAN's blood gas products fall under Class C NPT (Near-patient Testing) in the IVDR classification, representing the second-highest risk level.
EDAN’s management representative, Yongying Liu, expressed, "EDAN acquired CE marking in 2002 and FDA registration in 2004, expanding certifications in China, EU, the United States, Canada, Brazil, and Russia. Our prompt response to new regulations and swift IVDR certification mirror our steadfast commitment to stringent quality management, ensuring global excellence.”
EDAN's achievement as one of the pioneering recipients of China's IVDR CE certification is rooted in its robust and efficient Quality Management System (QMS). Prioritizing quality above all else, EDAN consistently delivers stable and secure medical equipment to customers worldwide. Renowned for its guaranteed quality and exceptional services, EDAN's IVD products and solutions grace numerous top-tier hospitals and laboratories across Europe.