Bio plasma deep-tech company Plasmapp (405000) announced on May 12 that its implant surface activator product, Actilink, has recently received CE MDR (Medical Device Regulation) certification in Europe.

The CE MDR certification is a regulation established by the European Union to ensure that medical devices are safe and effective for patient use. Compared to the previous CE MDD (Medical Device Directive), it imposes stricter requirements for product quality, safety, performance, efficacy, and clinical validation.

Obtaining CE MDR certification is essential for selling medical devices in the EU and in countries that recognize CE marking.

Plasmapp’s Actilink is a device that emits plasma onto the surface of implants to restore their original biocompatibility. It improves the implant's hydrophilicity and protein adsorption properties, thereby significantly shortening the stabilization period after surgery through enhanced biocompatibility.

The device also offers the advantage of reactivating implants through plasma treatment in just one minute before surgery. This process removes hydrocarbons and other surface contaminants that may have formed or adhered to the implant.

With this certification, Plasmapp is now positioned to directly target the European implant market, which is valued at approximately $1.7 billion (around KRW 2.5 trillion). The company is expected to strengthen its presence in Europe and expand its competitiveness on the global stage.

A Plasmapp representative stated, “The CE MDR certification carries significant meaning as it officially verifies the clinical efficacy and validity of Actilink in the highly regulated European medical device market. Especially notable is that this is the first certification in the world for a medical device used immediately prior to implant surgery, which we believe will allow us to lead the market.”

They added, “We will continue working to improve treatment convenience for patients and to provide trusted solutions to healthcare professionals, aiming to expand Plasmapp’s role globally and maintain a leadership position in the industry.”

Source : https://www.newsprime.co.kr