ELLISYS SENSE by Chungwoo Medical Earns EU MDR Certification Strengthening Global Competitiveness with Proven Safety and Performance

Seoul, Korea South, 11th Jul 2025 - CHUNGWOO MEDICAL Co., Ltd., a specialized manufacturer of energy-based aesthetic and medical devices, announced on June 26 that its fractional microneedle RF device, ELLISYS SENSE, officially obtained certification under the European Union’s Medical Device Regulation (MDR) on April 9.

The EU MDR, which took effect in 2021, is the latest and most stringent regulatory framework for medical devices in the European Union. Compared to the previous MDD, it requires enhanced standards for product safety, clinical efficacy, risk management, and technical documentation.

With this certification, ELLISYS SENSE has demonstrated its reliability and competitiveness in the European market, and CHUNGWOO MEDICAL is now better positioned to accelerate its global expansion.

About ELLISYS SENSE

ELLISYS SENSE is an advanced fractional microneedle RF (Radiofrequency) device that delivers precise electrothermal energy and deep tissue coagulation through electronically controlled microneedles.

It features a two-in-one RF system that supports both monopolar (1 MHz) and bipolar (1 & 2 MHz) modes, enabling versatile applications for conditions such as acne scars and tissue regeneration.

The device also includes a Dual-Depth Double Shot function, allowing for highly targeted and effective treatments even in delicate areas such as the lower eyelids and submental region (double chin).

Thanks to its ergonomic design and precise energy control system, ELLISYS SENSE offers both practitioner convenience and high patient satisfaction. It has been well received in dermatology and aesthetic clinics around the world.

 

Mr. Ilkwon Lee, CEO of CHUNGWOO MEDICAL, stated: 

“This MDR certification is a recognition of ELLISYS SENSE’s technical excellence and safety in line with European standards. We plan to strengthen our distribution partnerships across key European countries and reinforce brand positioning through academic activities and global exhibitions.”

Currently, ELLISYS SENSE is actively exported to Europe, the Middle East, Asia, and South America, with continued product upgrades and regional adaptations based on clinical data and user feedback worldwide.

Learn more at: www.mycw.co.kr 

About CHUNGWOO MEDICAL

CHUNGWOO MEDICAL Co., Ltd. is a Korea-based manufacturer specializing in energy-based aesthetic and medical equipment, including radiofrequency (RF), laser, HIFU, electrosurgical, and neuromuscular stimulation technologies. With over 20 years of technical expertise and manufacturing experience, the company exports its proprietary branded devices to over 60 countries, serving dermatology, plastic surgery, and aesthetic clinics worldwide.
CHUNGWOO provides a total solution—from product planning and development to certification, manufacturing, and global marketing. The company holds major global certifications including ISO 13485, GMP, CE, and FDA, and is widely recognized for its flagship products such as ELLISYS Series, ROBOLEX, and APOLEX Tite, known for clinical safety and effectiveness in both domestic and international markets. CHUNGWOO MEDICAL continues to lead innovation and pursue quality-driven management aligned with global standards to become a top-tier company in the aesthetic medical industry.

Media Contact

Organization: CHUNGWOO MEDICAL

Contact Person: Jinny, Noh

Website: http://www.mycw.co.kr/

Email: Send Email

City: Seoul

Country:Korea South

Release id:30548

The post ELLISYS SENSE by Chungwoo Medical Earns EU MDR Certification Strengthening Global Competitiveness with Proven Safety and Performance appeared first on King Newswire. This content is provided by a third-party source.. King Newswire is a press release distribution agency. We do not accept any responsibility or liability for the accuracy, content, images, videos, licences, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright concerns related to this article, please contact the company listed in the ‘Media Contact’ section above.