Following its milestone achievement on January 9, 2025—when the Eighteeth CBCT FinScan F350 became the first Chinese-made 3-in-1 CBCT to obtain both NMPA and FDA certifications—FinScan F350 has now added another significant accomplishment. On August 22, 2025, it successfully earned CE certification, becoming the first CBCT from China to achieve the NMPA, FDA, and CE “triple crown”, once again demonstrating Eighteeth’s leadership in innovation, product quality, and clinical excellence.
The CE certification serves as the entry passport to the EU medical device market, signifying compliance with Europe’s rigorous standards for safety, performance, and quality management.
● High barrier to entry: Devices must undergo multiple rounds of stringent testing and clinical validation, covering product design, manufacturing, performance, and quality control.
● Global recognition: Earning CE certification means the product meets world-class standards, enabling legal sales across Europe and gaining the trust of clinicians and regulatory authorities worldwide.
This achievement not only highlights the FinScan F350’s exceptional imaging accuracy, system stability, and clinical safety but also marks a significant step forward for Chinese CBCT technology in meeting international benchmarks.
With the backing of these three major certifications, the FinScan F350 is set to deliver safer, more reliable, and more efficient digital imaging solutions for dental professionals and lay a strong foundation for Chinese CBCT to expand in global markets.