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[Shin-Min Joon, Edaily Reporter] Huons Meditech, a medical device company of Huons Group is making a move to enter the European market with its digital infusion system.

The official ceremony for the presentation of the CE MDR certificate took place at Huons Meditech’s headquarter in Seongnam, South Korea on August 21. (Image=Huons Meditech)

Huons Meditech announced on August 22 that it has received MDR (Medical Device Regulation) CE marking for its digital infusion system, ‘Dermashine Pro’ and ‘Dermashine Balance’.

This CE marking awarded to Huons Meditech, particularly under the recently enhanced MDR signifies that Dermashine Pro and Balance meet stringent European standards for safety and performance. This marks the first CE MDR certification for a digital infusion system from a company based in Korea.

Dermashine is Huons Meditech’s signature brand for skin aesthetic medical devices featuring precise drug infusion function and user friendly design interface. The device is used to inject medications, such as Elravie Balance, a high molecular weight, high concentration hyaluronic acid (HA) with skin moisturizing effects, to the entire face.

The newly CE certified Dermashine Balance and Pro are next generation products built on the first generation Dermashine device, launched in 2011. They feature an infusion sensing system along with more refined drug volume and speed settings.

The company plans to officially enter the European market leveraging the EU MDR CE mark for the Dermashine series. Huons Meditech plans to establish itself as a global brand starting with its European launch and then expanding into Asia and the Americas.

CEO of Huons Meditech Lee Jin suk said “This CE MDR certification will serve as a significant milestone for Huons Meditech’s global expansion including the European market. We will continue to drive innovation, develop superior products and promote the excellence of K-Medical devices.”