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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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