Dyne Medical Group’s URUS™ Receives US FDA 510(k) Clearance, Enters US Market

관리자
8 Sep 2024
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[Seoul, Korea] – Dyne Medical Group proudly announces that its flagship product, URUS™, has received US FDA 510(k) Clearance, enabling its immediate availability in the United States.

URUS™ represents a breakthrough in the medical device industry, offering healthcare professionals a high-performance, disposable endoscope designed to meet the rigorous demands of modern medical practice. Known for its superior quality and innovative design, URUS™ is set to provide American healthcare providers with the reliable tools needed to deliver exceptional patient care.

“Achieving FDA 510(k) clearance is a major milestone for Dyne Medical Group and underscores our commitment to the highest standards of safety, quality, and innovation,” said Sunghoon Lee, CEO of Dyne Medical Group. “We are excited to bring URUS™ to the US market, where we are confident it will make a significant impact in improving healthcare outcomes.”

The FDA’s 510(k) clearance signifies that URUS™ meets the stringent requirements of safety and efficacy, in line with the latest standards for medical devices in the US. With this clearance, Dyne Medical Group is poised to expand its global footprint, offering solutions that align with the needs of healthcare professionals in one of the world’s largest medical device markets.

Dyne Medical Group’s entry into the US market reinforces its mission to provide cutting-edge, high-quality medical technologies that enhance patient care worldwide. URUS™ has already gained international recognition for its exceptional performance and is expected to be a trusted choice for hospitals and clinics seeking top-tier medical solutions.


About Dyne Medical Group

Dyne Medical Group is a global leader in the development and manufacturing of innovative medical devices. Specializing in high-performance, disposable endoscopic solutions, Dyne Medical Group is committed to delivering excellence in healthcare technology to improve patient outcomes. With a strong focus on research and development, Dyne Medical Group continues to pioneer advancements in medical devices that set new standards for quality and reliability.


The content on this page is intended for healthcare professionals, as well as individuals who are qualified equivalents, such as researchers or regulatory personnel, with an interest in medical devices and related information. Please note that the intended audience may vary based on local laws and regulations governing medical devices and related information.


The content on this page is intended for healthcare professionals, as well as individuals who are qualified equivalents, such as researchers or regulatory personnel, with an interest in medical devices and related information. Please note that the intended audience may vary based on local laws and regulations governing medical devices and related information.

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