Huons Meditech Secures CE MDR Mark for Dermashine Pro and Balance
First Korean digital infusion system to achieve CE MDR approval, paving the way for European entry
Huons Meditech, a subsidiary of Huons Group, has received CE MDR (Medical Device Regulation) certification for its digital infusion systems, Dermashine Pro and Dermashine Balance.
The certification, announced on August 22, makes Huons Meditech the first Korean company to obtain CE MDR approval for a digital infusion system. The CE MDR mark signifies compliance with the European Union’s stringent safety and performance standards and clears the path for Huons Meditech to expand into the European market.
Dermashine is Huons Meditech’s flagship brand of skin aesthetic devices, designed for precise drug infusion with an intuitive user interface. The system is commonly used to administer medications such as Elravie Balance, a high-molecular-weight, high-concentration hyaluronic acid that provides skin-moisturizing benefits.
The newly certified Dermashine Balance and Pro build upon the original Dermashine, first launched in 2011, with next-generation upgrades including infusion-sensing technology and enhanced drug volume and speed control.
Leveraging the CE MDR approval, Huons Meditech plans to launch its Dermashine series in Europe, followed by further expansion into Asia and the Americas.
“Our CE MDR certification represents a major milestone in our global strategy,” said Huons Meditech CEO Lee Jin-suk. “We will continue to drive innovation, deliver advanced medical devices, and showcase the excellence of K-Medical worldwide.”