Huons Meditech, a medical device affiliate of Huons Group, said Friday it has obtained European CE-MDR (Conformité Européenne – Medical Device Regulation) certification for its digital infusion system Dermashine Pro and Dermashine Balance, paving the way for its entry into the European market.

According to the company, the certification under the tightened EU Medical Device Regulation  demonstrates the safety and efficacy of the devices, making them the first digital infusion system developed by a Korean company to receive the approval.

Dermashine is Huons Meditech’s skin aesthetics device brand designed for precise drug delivery with a user-friendly interface. The system injects high-molecular, high-concentration hyaluronic acid formulations such as Elravie Balance across the face to enhance skin hydration.

The newly certified Dermashine Pro and Dermashine Balance are next-generation models of the company’s original Dermashine, first launched in 2011. The upgraded versions feature a pressure-sensing injection system, as well as enhanced control of drug dosage and injection speed.

The company plans to leverage the CE-MDR certification to launch its Dermashine series in Europe, with further expansion planned into Asia and the Americas as part of its strategy to establish the brand as a global leader in aesthetic medical devices.

“This CE-MDR certification is a significant milestone for our global expansion, including the European market,” Huons Meditech CEO Lee Jin-suk said. “We will continue to drive innovation, develop high-quality products, and promote the excellence of Korean medical devices worldwide.”