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UMT Obtained the First Batch of MDR CE Certificates in China

United Medical Technologies, obtained the emergency filing certificate of disposable medical mask and medical surgical mask on February 29. On May 14, UTM successfully obtained the CFDA class II Registration Certificate of disposable medical mask and medical surgical mask. On May 19, UMT appeared on theName List of Medical Devices and Supplies Companies with Certification/Authorization from other Countries. (commonly known as "white list") of China Chamber of Commerce for the Import and Export of Medical and Health Products, and recently obtained CE certificate on June 15, 2020, which is the first CE certificate under the framework of the new EU regulation MDR.


For MDD, MDR is a comprehensive upgrade and therefore a challenge to the quality system of medical device companies. In a short period of time, UMT upgraded its quality system to meet the requirements of MDR regulations and passed the audit successfully.

This means that with the tenet of "profession, focus, innovation and service", the good quality system, as well as safe, efficient and standard production mode have been recognized by EU regulations, and the products can enter the EU market in a more legal and compliant way, contributing to the overseas anti-pandemic situation.































对于MDD而言,MDR是全方位的升级,因此对于医疗器械公司的质量体系是一个挑战。优特医疗在短期内将自身的质量体系升级到符合MDR法规要求,并且顺利通过了审核。


这意味着优特医疗以“专业、专注、创新、服务”的宗旨,良好的质量体系、安全高效、标准生产的模式获得了欧盟法规的认可,优特医疗的产品能够更加合法合规地进入欧盟市场,为海外疫情贡献出一份力量。

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