2 Critical Testings for Face Mask You need to know

ISO 10993-5 ISO 10993-10 Testing

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….

【CE Mark】| 5 Steps to get CE Mark

CE Mark 認證

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.