Recently, Sanqi medical FFP2 mask won the EU CE certification! As the EU product safety certification standard, EU CE system certification is regarded as the passport for the manufacturer to open and enter the European market. It is the certification that must be required before all medical devices entering the EU market. However, only a few domestic FFP2 medical protection products manufacturers have obtained the EU CE certification.
Sanqi medical has passed the EU CE certification, which is an affirmation of Sanqi quality. It is also a kind of honor for Sanqi, and also a symbol of being in the forefront of the world's medical device industry!
As a benchmark enterprise of medical devices, Sanqi medical has been deeply engaged in the medical industry for many years. During the period from June 29 to July 17.2020,Sanqi medical depended on its rich experience,cutting-edge technology and enterprise spirit of facing difficulties, and after several rectification, we successfully obtained the EU CE certification of FFP2.
In strict accordance with the requirements of medical device directives, standards and relevant laws and regulations of the regulations on personal protective equipment (EU), the experts of the audit team reviewed the FFP2 certification products applied by Sanqi enterprises, and deeply communicated with the leadership of the company to fully understand the implementation and operation of the EU CE system of Sanqi.
After strict review, the expert group believes that the quality of FFP2 product of Sanqi enterprise is controllable, the operation of EU CE system and the implementation of medical device directive of personal protective equipment regulation (EU) are in good condition. A series of certification audits show that the product meets the relevant technical requirements of EU medical devices and can be freely circulated in the EU market.
FFP2 mask is a kind of European mask standard en149:2001. It can absorb harmful aerosol (including dust, smoke, fog drop, poisonous gas and poisonous vapor) through filter material to prevent it from being inhaled by human body.