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Face Mask Regulations and Standards in the EUAn

Tobi Doeringer May 13, 2020 at 12:17 am . Do Type IIR masks need a CE mark assuming they have passed all tests? EN says the requirements on the packaging are onlyBoth the Medical Device Directive (93/42 / EEC) and the Medical Device Regulation (EU) 2017/745 specify the information that should appear on the packaging in which the medical face mask is supplied.

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According to the standard, masks are divided into three categoriesFFP1 / FFP2 and FFP3. All masks exported from China to the EU must obtain CE certification. CE certification is a compulsory product safety certification system implemented by the European Union to

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