Lifting Device '10THERMA' Passes European Medical Device Regulation (MDR) Following U.S. FDA Approval

TENTECH Inc., a manufacturer specializing in medical device, announced that its flagship model, the monopolar radiofrequency (RF) medical device '10THERMA', has obtained the European Medical Device Regulation (CE MDR) certification.
This certification is considered to have once again proven K-technology's quality, as its requirements were significantly strengthened for safety and clinical performance compared to the previous Medical Device Directive (MDD) certification.
Han Dong-ok, CEO of TENTECH, stated, "Following the U.S. FDA (Food and Drug Administration) approval, our monopolar RF lifting device '10THERMA', which delivers a maximum output of 400W, has obtained CE MDR (Medical Device Regulation) certification from the European notified body. We plan to expand our export channels to major European countries, including Germany, France, Italy, and Spain, as well as to Middle Eastern and Asian countries that recognize the CE certification."
The CE MDR, which the European Union (EU) made mandatory in 2021 to replace the previous MDD, applies much stricter standards throughout the entire process, including the quality of clinical data, post-market surveillance, and technical documentation review. Notably, '10THERMA' has been highly praised for its superior treatment speed and pain control with its tip area, which is more than 25% larger than competitors' products, and TENTECH's proprietary cooling system (S.T.C).
Based on this certification, TENTECH plans to finalize agreements with local European distributors and launch large-scale marketing campaigns.
CEO Han Dong-ok expressed his ambition, stating, "Using the CE MDR certification as a stepping stone, we will promote the excellence of 'K-Beauty Devices' across Europe and maximize TENTECH's corporate value."