Bio-plasma deep tech company Plasmapp announced on May 12 that its implant surface activator product, Actilink, has successfully acquired 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), the MDR imposes stricter requirements on product quality, safety, performance, efficacy, and clinical validation. The CE MDR certification is essential for selling medical devices in the EU and other markets that recognize CE marking.

Actilink is a device that irradiates plasma onto the surface of dental implants to restore their inherent biocompatibility. By enhancing the hydrophilicity and protein adsorption of implants, it significantly reduces the healing time after surgery through improved biocompatibility.

Additionally, the product offers a notable advantage by regenerating and activating implants through a quick plasma treatment in under one minute before surgery. This process removes hydrocarbons and impurities attached to or generated on the implant surface.

With this certification, Plasmapp is now positioned to directly target the European implant market, which is valued at $1.7 billion (approximately 2.5 trillion KRW), and is expected to expand its competitiveness in both European and global markets.

A company representative stated, “This CE MDR certification holds great significance as it officially recognizes the clinical effectiveness and validity of Actilink in the highly regulated European medical device market. Especially noteworthy is that Actilink is the first product in the world to receive this certification as a pre-surgical implant device, positioning it as a leader in its field.”

The representative added, “We will continue our efforts to improve patient care and provide reliable solutions to healthcare professionals, further expanding Plasmapp’s global presence and maintaining our leadership in the market.”

Source : http://www.bosa.co.kr