ALEEN masks update EU medical regulation registration
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 kn95 masks are listed by the US FDA
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.
ALEEN kn95 mask passed the US standard test for protective masks
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
ALEEN Mask Updates China Protective Mask Test
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
ALEEN masks are 510(k) approved
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.
ALEEN masks are tested in the intertek laboratory
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 masks passed ISO13485 certification
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
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 masks are registered by TGA
ALEEN medical masks have obtained TGA registration in Australia, which means that the product can be legally sold in the Australian medical market.
ALEEN masks passed the TUV test
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.