Meeting European Safety and Quality Standards, Laying the Foundation for Expanding in the Global Mobile X-ray Market
DRGEM (CEO J. B. Park), a global medical imaging solutions company, announced that its next-generation mobile DR system, ‘RAYMO’, has obtained the European Union’s CE MDR (Medical Device Regulation) certification. This achievement follows the acquisition of US FDA clearance last May. Through this milestone, DRGEM will pass the key gateway into the European market and accelerate its global business expansion.
The EU requires CE MDR certification to ensure products meet strict safety, quality, and performance standards. It serves as an essential requirement for selling medical devices in the European Economic Area (EEA) and many other countries. With this certification, DRGEM secures a solid sales foundation in Europe and strengthens its position to expand global customers and partnerships
DRGEM Accelerating Overseas Growth Based on a Global Network in Over 130 Countries
RAYMO is DRGEM’s newly introduced mobile DR system. It supports fast and accurate imaging in various clinical environments. The system features an RFID-based user recognition function that automatically applies customized settings for each medical staff member. Additionally, various smart functions enhance mobility and user convenience to improve work efficiency.
Global demand for mobile X-ray equipment is growing rapidly. In this market, the CE MDR certification highlights RAYMO’s technological prowess and product competitiveness. Taking this opportunity, DRGEM plans to strengthen its sales activities in major European countries and actively expand local partnerships.
This certification does more than just secure sales qualifications; it objectively verifies the product’s safety, quality, and reliability. Therefore, the company expects it to boost adoption by overseas medical institutions and distribution partners.
J. B. Park, CEO of DRGEM, said, “Obtaining the CE MDR certification officially recognizes RAYMO’s global-level technology and quality.” He added, “We will expand global partnerships focusing on the European market and further strengthen DRGEM’s position in the mobile X-ray market.”
Meanwhile, DRGEM specializes in digital radiographic imaging diagnostic solutions. The company expands its overseas business through a global sales and partner network in over 130 countries. Using RAYMO’s CE MDR certification as momentum, the company plans a full-scale entry into the European market to secure continuous growth globally.
