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….
The UK Government have introduced new UKCA conformity marking to replace CE Marking, and this will effective on 1st Jan 2021. The new UKCA Marking requirement will be used for products being placed on the market in Great Britain (England, Wales and Scotland), replacing the EU requirements for CE Marking.
Guide to import China KN95 Face Mask to EU Countries In China, there are two major type of Face Mask- 3 ply Face Mask and
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.