The EU will implement new regulations (MDR) on medical devices from May 2021. In order to meet the new requirements, ALEEN has made corresponding adjustments and improvements to the technical specifications related to masks and registered them again in the EU.

ALEEN’s KN95 masks are listed by the FDA and can continue to be sold in the US and North American markets in the new year.

The United States issued a new standard ASTM F3502-2021 for ordinary face masks, and ALEEN’s KN95 masks were tested under this standard, and the results were all qualified, providing confidence and assurance for the product to be sold in the United States and North America

According to relevant Chinese regulations, ALEEN’s KN95 masks have updated the implementation standards, and have been tested corresponding to GB2626-2019, and the results are all qualified with high standards

After a series of technical preparations and applications, ALEEN medical masks passed the 510(k) approval of the US FDA and obtained the qualification to be listed in the US medical market.There are two types of medical masks that have passed the application this time: ear-loop type and tie-on type.

In August 2020, ALEEN medical masks are ready to enter the U.S. market. Intertek, a well-known international organization, is responsible for testing. It has passed relevant tests such as biocompatibility and ASTM F2100, and the results have reached the highest level.

ALEEN medical masks have been adhering to strict production processes and standardized technical standards, so that they have successfully obtained the approval of ISO13485 (Medical devices—Quality management systems—Requirements for regulatory purposes), which means that ALEEN medical masks have reliable good quality

ALEEN masks are registered with the German Health Agency In May 2020, ALEEN masks were registered with the German Health Agency, indicating that the technical specifications and production process of ALEEN masks meet the relevant requirements of EU medical supplies and can be listed in Europe

ALEEN medical masks have obtained TGA registration in Australia, which means that the product can be legally sold in the Australian medical market.

In May 2020, ALEEN  masks passed the EN14683 test of TUV, and the test result was Type IIR level, which is the highest quality performance under this standard. At the same time, there are two specifications for adults and children who have passed this test, which basically covers the needs of most people for masks.