Wontech, a company specializing in laser and ultrasound equipment development, has secured CE MDR certification for three of its flagship products. The firm aims to expand its European market presence and sustain overseas business growth with these newly certified devices that meet enhanced European medical standards.
On Wednesday, Wontech announced CE MDR certification for three products: the picosecond Nd:YAG laser PicoCare, the 1927 nm thulium laser Lavieen, and the high-intensity focused ultrasound (HIFU) device Titan Pro.
CE MDR, the European Union’s medical device regulation, imposes stricter requirements for clinical evidence and post-market safety management compared to previous directives. Wontech plans to pursue additional product certifications to broaden its European product range.
Wontech’s international business plays a significant role in its overall revenue. In the first half of this year, overseas sales reached approximately 657 billion KRW (about 491 million USD), accounting for 74.9% of total sales.
The company currently supplies products to over 80 countries and has secured approvals in markets including the U.S., Japan, Brazil, Saudi Arabia, Australia, and Thailand.
Notably, U.S. market sales surged by 127.4% in the second quarter compared to the same period last year. Wontech aims to expand collaboration with local partners in Europe, focusing on certified products, while also targeting entry into other overseas markets from its European base.
CE MDR certification not only facilitates Wontech’s European market entry but can also serve as a credibility booster in approval processes for other countries. The company plans to integrate regulatory approval with overseas sales from the product development stage to accelerate new product market entry.
A Wontech spokesperson stated that this MDR certification is not the end but a starting point. It will systematically expand our certified product lineup to accelerate the European market penetration and drive growth in the global business.
Meanwhile, Wontech continues to expand its presence in major Asian markets, maintaining stable revenue growth. This year, the company plans to conduct its global brand event Wave in key Asian countries, including Japan and China, to strengthen connections with local medical professionals and consumers. By positioning its Oligio line as a premium brand, Wontech aims to further enhance brand trust and market presence.
