There are two ISO 10993-5 & ISO 10993-10 testings which are critical when applying CE Registration.
In the market, most of consumers focus the percentage of BFE & VFE, Class / type of Face Mask, the product of origin….
In China, there are two major type of Face Mask- 3 ply Face Mask and KN95 Face Mask. The EU Medical Device Directive /Medical Device Regulation and Personal Protective Equipment Regulation control and regulate the import and sales of Face Mask in Europe. The below table show the different regulations between China Regulation and EU …
CE Mark registration
If the medical device is manufactured in the EU country, the manufacturer can apply directly to the local government agency (Competent Authority). If the medical device is manufacture outside of EU, the EU authorized Representative assists the manufacturer to apply CE Registration.