Chungwoo Medical Achieves European MDR Certification for ELLISYS SENSE

Chungwoo Medical announced that its ELLISYS SENSE received European Medical Device Regulation (MDR) certification. This achievement represents a significant milestone for the company in the medical equipment industry.

Understanding MDR Certification

The MDR certification, effective since 2021, introduces stricter safety and efficacy requirements for medical devices in the EU. It ups the ante compared to the previous Medical Device Directive (MDD) by focusing more on:

Product safety
Clinical effectiveness
Risk management
Technical documentation

ELLISYS SENSE met these rigorous standards, proving its reliability and engineering excellence.

ELLISYS SENSE Features

ELLISYS SENSE is a high-frequency device using micro-needle radiofrequency (RF) technology. Here’s what makes it stand out:

Dual-mode RF System: It supports both 1MHz monopolar and 1/2MHz bipolar RF, making it versatile for various medical applications.
Tissue Coagulation: It ensures deep tissue coagulation for effective treatment outcomes.
Use Cases: Primarily used for acne scar treatment and tissue regeneration.

Expansion Plans for ELLISYS SENSE

Following the MDR certification, Chungwoo Medical plans to expand its footprint across major European markets. The company aims to boost its brand presence through:

Distribution partnerships
Participation in international exhibitions
Engagement in academic activities

Global Reach

ELLISYS SENSE is not only gaining traction in Europe but is also expanding in:

Middle East
Asia
South America

This global expansion reflects the device’s growing popularity and effectiveness, backed by clinical data and user feedback.

Continuous Improvement

Chungwoo Medical commits to upgrading the technology based on user insights and clinical research. This approach will drive ongoing innovation and ensure that ELLISYS SENSE remains competitive globally.

Conclusion

ELLISYS SENSE’s European MDR certification signals trust in its quality and efficacy. As Chungwoo Medical extends its reach, more regions can benefit from this advanced medical technology.