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Manufacturers have to characterize and classify surgical face masks in type I or II in the European market and in level 1, 2 ot 3 for the American market. Evaluation of surgical masks in Europe. In Europe, surgical masks must wear a CE mark and comply with the requirements defined in EN 14683: Medical face masks - Requirements and test methods.
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Apr 14, 2020 · Approvals Required to Meet the Requirement of Face Mask and PPE Kit License CE Certification has become an essential requirement for products to get sold in the EU. CE Marking states that the manufacturer has assessed the product properly, and there is an interpretation that CE marking meets the requirements of EU safety, health as well as ...
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