Daegu Company 'Lowtem' Develops Medical Sterilizer, Obtains European MDR Certification and Also Receives US FDA Approval
K-MEDI Hub (Daegu-Gyeongbuk Medical Innovation Foundation, Chairman Yang Jin-young) announced on the 3rd that Lowtem Co., Ltd., a tenant company in the Advanced Medical Complex, recently obtained the European CE MDR certification for its medical low-temperature plasma sterilizer.
Lowtem Co., Ltd. (CEO Lee Sang-il) is a specialized manufacturer of low-temperature plasma sterilizers, having obtained CE MDD approval in 2011. Since 2020, the company has been striving to prove the safety and performance of its products for CE MDR approval, and as a result, obtained certification last September, signaling a green light for entry into the global market.
The CE MDR certified models are the ‘LOWTEM Crystal 120’ and ‘LOWTEM Smart 150’ products.
Lee Sang-il, CEO of Lowtem Co., Ltd., stated, “Recently obtaining the European CE MDR certification along with the US FDA approval is not the achievement of one person, but the result of the patience and challenge of the executives and employees who share the company’s vision and purpose,” adding, “We will continue to invest in long-term talent development and nurturing as well as future technologies.”
The European Medical Device Regulation (MDR) is a regulation implemented by the European Union (EU) to strengthen the safety and performance of medical devices.
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Implemented in 2021, the MDR replaces the existing Medical Device Directive (MDD) and strictly regulates the overall management system including medical device design, manufacturing, clinical evaluation, and certification procedures. It is an essential requirement for entering the European market and is regarded as an important certification in the global market.
Yang Jin-young, Chairman of K-MEDI Hub, said, “The product of tenant company Lowtem has proven its world-class level by obtaining CE MDR certification following FDA approval,” and added, “K-MEDI Hub will also lead the development of the national advanced medical industry with global-level research capabilities.”
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