Mekics Obtains European CE MDR Certification for Next-Generation Hybrid Ventilator 'MV50'

Mekics, a company specializing in medical devices, has obtained the CE MDR certification under the European Medical Device Regulation for its next-generation hybrid ventilator, the MV50, accelerating its entry into the global respiratory care device market. The company plans to leverage product competitiveness, emphasizing the capability to handle everything from emergency transport to intensive care units (ICUs) with a single device, as it seeks to expand into overseas markets, including Europe.

On September 15, Mekics announced that the MV50, developed with its proprietary technology, has acquired the European CE MDR certification. CE MDR is the European Medical Device Regulation that demands higher safety, clinical effectiveness, and quality management standards than the previous Medical Device Directive (MDD).

With this certification, Mekics has established a foundation to enter global markets, including the 27 member states of the European Union, as well as countries in the Middle East, Asia, and Latin America, where the CE certification is adopted as a primary regulatory standard or reference model.

The MV50 is a hybrid ventilator that integrates mobility and advanced critical care performance into a single platform. It is designed to meet all needs in environments ranging from emergency rooms and patient transport to the demanding intensive care required in ICUs.

In particular, the MV50 allows continued patient treatment without replacing the ventilator during intra-hospital patient transfer, which extends ongoing therapy. This not only reduces the burden on medical staff from equipment changes but also ensures continuity in patient care.

In the global ventilator market, technology is shifting from models relying on central compressed air supply systems (Central Gas Line) to those using a built-in motor and blower, enabling independent air supply and precise respiratory control.

Mekics has responded to these market trends by developing blower-based ventilator technology and launching the MV50. The company’s strategy is to address the diverse needs of global clinical settings with a product that combines both portability and advanced critical care functions.

In non-European markets, the MV50 has already demonstrated its competitiveness through exports and sales prior to obtaining CE MDR certification. Now, with this certification, the company plans to expand its supply network not only in mainland Europe but also in countries that reference the CE standard, aiming to increase its global market share.

Mekics expects the MV50 to become a next-generation key product that drives both revenue and profitability in the future.

Kim Jongcheol, CEO of Mekics, stated, "Obtaining CE MDR certification for the MV50 is a significant achievement, proving that our blower-based ventilation technology and hybrid product competitiveness meet the world’s most stringent regulatory standards. Building on our unrivaled technological capabilities spanning from emergency transport to intensive care, we will continue to expand our business domain and position in the global respiratory care market."

This content was produced with the assistance of AI translation services.