Certification covers all three dental imaging categories and every 2026 model launch
HWASEONG, South Korea, June 10, 2026 /PRNewswire/ — Vatech (KOSDAQ: 043150), a global leader in dental imaging, today announced the completion of EU Medical Device Regulation (MDR; Regulation (EU) 2017/745) certification across its entire dental imaging portfolio — covering all existing commercial models and every newly launched 2026 model. The certifying body is DNV Product Assurance AS, a Notified Body designated under EU MDR.
Full-Portfolio Transition in a Market Pulling Back
According to a study by the consultancy EY, commissioned by the European Commission, more than half of medical device companies in the EU have reduced their product portfolios due to MDR compliance demands. Against this backdrop, Vatech maintained its full product lineup without reduction and secured certification for all newly launched 2026 models — including premium models — through a single conformity assessment. The result stands in clear contrast to the partial-lineup or single-product certifications that have characterized much of the industry’s MDR response.
“At Vatech, our position has always been straightforward: clinicians should be able to continue using the solutions they depend on, and patients deserve uninterrupted access to the latest diagnostic innovations,” said Brian Hwang, Chief Executive Officer of Vatech. “Completing this transition in full — at a time when the industry norm has been to pull back — reflects what we believe global leadership in dental imaging requires.”
New Models Certified Before Launch — Clinical Access From Day One
All models newly launched in 2026 — including the premium Green X 21, Green X Plus, Green X 12 Plus, and Green X 12 SE — are included within the certified scope. With regulatory clearance already secured across multiple major jurisdictions, and EU MDR certification now in place, these solutions are available for immediate European distribution from the moment they launch — with no post-launch certification gap and no interruption to patient care.
Europe as a Foundation — and a Gateway
Vatech has established a strong clinical presence across Europe’s key dental markets, where its imaging solutions are among the most widely adopted by dental practices, hospital networks, and group clinics. The company’s full-portfolio MDR certification ensures that this presence is sustained without interruption under the new regulatory framework.
The reach extends further. CE certification carries significant weight as a market access benchmark across Southeast Asia, the Middle East, and Latin America — markets where demand for advanced dental imaging continues to grow. Full-portfolio MDR certification positions Vatech’s complete lineup for broader clinical adoption across these regions as well.
About Vatech
Vatech (KOSDAQ: 043150) is a global leader in dental imaging innovation, trusted by dental professionals in more than 100 countries worldwide. The company offers a comprehensive portfolio of dental diagnostic solutions — from intraoral X-ray systems and digital panoramic platforms to cone-beam CT systems and integrated diagnostic software. Headquartered in Hwaseong, Korea, Vatech is listed on KOSDAQ (043150). For more information, visit www.vatech.com.
