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    Normally, medical face masks require a CE mark in the EU. In accordance with EN 14683, the test report from Hohenstein may be used as one of the technical documents required for EU medical product certification. Other comprehensive tests and clinical evaluations are also required for approval.

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  • Do I need CE marking?

    The CE marking applies to products placed in the market or put into service in the European Economic Area, and only for certain product groups or product aspects. Thus in order to answer the question whether a product needs to be CE certified, one has to determine first in which countries the products are going to be placed in the market or

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  • CE Mark Frequently Asked Questions BSI Australia

    CE marking is a declaration by the manufacturer that the product meets all the appropriate provisions of the relevant legislation implementing certain European Directives. CE marking gives companies easier access into the European market to sell their products without adaptation or rechecking. The initials "CE" do not stand for any specific

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    5.QDo your company have any quality management system such as ISO, EN or CE certificate(s)? A:AOK has passed the IS09001 2008 quality system certification, and has passed the GTTC certification (T/CTCA 7 2019), the US Disney inspection. 6. QHow do you solve quality issues if