Genoray Secures CE MDR Certification for 'OSCAR 15FD' and 'BELLIGER ACE' (2026.03.13)

Global X-ray imaging medical device specialist Genoray (CEO Park Byung-wook) announced that its entire C-arm lineup, including its strategic new products 'BELLIGER ACE' and 'OSCAR 15FD', 

has received CE MDR certification. This certification is particularly significant as it further solidifies the company's strong market position in Korea with the ▲BELLIGER ACE and

the ▲OSCAR 15FD, which targets high-end markets led by the Americas and Europe. With the certification of these two new products, 

the company has expanded its C-arm business spectrum, enabling it to meet all demands from the all-in-one entry-level market to the high-output, large-area FPD market.

CE MDR (Medical Device Regulation) is Europe's new medical device regulation, which has

significantly strengthened standards for safety, efficacy, and clinical evaluation compared to the existing CE MDD (Medical Device Directive). This certification proves that Genoray's quality meets 

global standards. A Genoray representative stated, "The fact that our entire C-arm lineup has completed MDR certification proves our technical

maturity and regulatory compliance capabilities," adding, "This not only enhances customer trust in our existing products but also 

provides the momentum to drive full-scale global sales growth for our new products."

Meanwhile, following a government tender contract worth approximately 3 billion KRW in Turkey late last year, Genoray has continued to expand its achievements by securing orders totaling 17 billion KRW in Brazil and 

Russia this January. With the addition of the CE MDR certification for the entire C-arm lineup to these large-scale supply contracts for existing flagship models,

the company has secured a foundation for entering the European market. The company's strategy is to accelerate overseas sales growth by reflecting the secured order volume in its revenue and expanding sales of new products in Europe, Africa, the CIS, and 

Asia.