RF Medical Completed the Transition to European Medical Device Regulations (MDR) for Class IIb Medical Devices
SEOUL, South Korea, Oct. 24, 2023 /PRNewswire/ -- RF Medical, specializing in the treatment of tumors and veins with various radiofrequency ablation products, announced today that they successfully completed the transition to the European Medical Device Regulation (MDR) CE Certification.
The European Medical Device Regulation, also known as CE MDR, strengthens the existing European Medical Device Directive (CE MDD). The requirements for product quality, safety, performance effectiveness, and clinical evaluation have become more stringent under the MDR. Medical device manufacturers wishing to commercialize their products in Europe must comply with this regulation.
The MDR certificate encompasses all of RF Medical's product portfolios previously compliant with the MDD. This includes RF generators, such as MYGEN M-3004, MYGEN V-1000, and VeinCLEAR V-700, as well as RF electrodes including Big-Tip, JET-TIP, THYBLATE, MYOBLATE, and VeinCLEAR catheters. The acquisition of this certificate ensures the continuous supply of these products to the European market.
RF Medical's transition to the new regulations not only positions the company for sustained success in the global medical device market but also underscores its dedication to delivering reliable medical solutions to healthcare practitioners and patients.
An official from RF Medical commented, "We are delighted to have reached another significant milestone in RF Medical's 20-year journey of developing and commercializing minimally invasive ablation devices." He further added, "Thanks to our unwavering commitment to quality enhancement and system improvement, the company can continue to align with global standards."
About RF Medical
RF Medical Co., Ltd., headquartered in South Korea, has been at the forefront of the medical industry for over two decades, specializing in the manufacturing of minimally invasive solutions for tumor treatment. With advanced technology and proven quality, we have extended our product reach to more than 60 countries across the globe. RF Medical's primary mission is to consistently enhance patient outcomes across a diverse range of treatment modalities. We strive to stay at the cutting edge of medical technologies and to lead the way in innovation. As a leading medical device company, RF Medical is dedicated to continuous investments in a superior workforce, manufacturing processes, innovation, and research and development. Pioneering the future, we are committed to developing effective, affordable, and less-invasive medical technologies.
For more details, visit RF Medical's official website. Stay connected with RF Medical on LinkedIn and Instagram, and explore products and patient videos on their YouTube channel.
RF Medical Contact
Public Relations
Email: overseas@rfa.co.kr
Phone: +82-2-2108-4200
Website: www.rfa.co.kr
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SOURCE RF Medical Co., Ltd.
