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Title: 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 SENSEELLISYS 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 w...

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