Huons Meditech, a medical device company within the Huons Group, has begun targeting the European aesthetic drug-delivery system market with its Dermashine product line.
Huons Meditech said Tuesday that it recently received European Medical Device Regulation (CE-MDR) certification for its Premium 9-Pin Needle, a dedicated microneedle for skin booster injections.
Huons Meditech’s Premium 9-Pin Needle package designed for skin booster injections (Courtesy of Huons Meditech)
The Premium 9-Pin Needle is a disposable microneedle used in combination with Dermashine Pro and Dermashine Balance, which are electrically powered aesthetic drug delivery systems. The needle features a laser-etched rotary controller for precise depth adjustment. Furthermore, it optimizes the bevel angle and length to minimize drug leakage during the procedure and reduce patient pain.
In August last year, Dermashine Pro and Dermashine Balance obtained CE-MDR certification. With this latest approval for the Premium 9-Pin Needle, Huons Meditech said it has demonstrated the safety and efficacy of its products under the recently tightened CE-MDR regulations, establishing a complete medical aesthetic platform that meets all European regulatory requirements.
Huons Meditech plans to leverage this CE-MDR certification to aggressively enter the European market. Starting with Europe, the company aims to expand into Asia, North America, and South America to establish itself as a global brand.
Huons Meditech CEO Ha Chang-woo said, “This CE-MDR certification will serve as a major milestone for our expansion into the global market, including Europe. We will continue to develop excellent products through continuous innovation and strive to promote the excellence of Korean medical devices globally.”
Kim Ji-hye
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