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Good news! CASP hydrogen peroxide low temperature plasma sterilizer has obtained the CE certificate under the MDR standard, marking a new chapter in the company's internationalization strategy

Posttime:2026-05-21 13:01:45 Hits:134

Recently, on May, 18, 2026, our company officially obtained the CE certificate under MDR(EU) 2017/745, signifying that our product fully complies with the latest EU medical device regulations.  This enables the product to legally enter the EU market and other global markets that recognize CE marking, laying a solid foundation for the company's international development.

On May, 26, 2021, the EU Medical Device Regulation (MDR) was fully implemented, replacing the previous Medical Devices Directive (MDD).  It introduces stricter and more comprehensive requirements in areas such as product safety, technical documentation, quality management, clinical evaluation and post-market surveillance, making the certification process significantly more challenging.

Facing the severe challenges posed by the upgraded regulations, the company has attached great importance to this matter, mobilizing core teams from R&D, quality, regulations, production, and export team to fully commit to advancing the certification process.  After multiple rounds of strict audits, we finally passed the comprehensive assessment and successfully obtained the MDR CE certificate.

The award of this MDR CE certificate not only represents official recognition by the European Union of the safety, efficacy and stability of CASP Hydrogen Peroxide Low Temperature Plasma Sterilizer, but also serves as a high commendation of the company's R&D capabilities, quality management standards and compliance capacity.

Obtaining MDR certification will further enhance the competitiveness of our products in international markets, support the company’s expansion of global business operations, and enable us to provide high-quality sterilization solutions that meet international standards to customers both domestic and abroad.  Moving forward, the company will take this MDR certification as a new starting point.  We will strictly adhere to the requirements of the EU MDR and regulations in major global markets, whilst continuously advancing technological innovation, improving product quality and optimizing our service systems, thereby fulfilling our corporate responsibilities to even higher standards.