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Regarding the export of masks to CE and FDA standards

by:Copper Plus     2021-06-20
Regarding the export CE and FDA standards of masks Recently, there are often news about the CE and FDA markings of masks. Some ports may prohibit the export of skins with the above-mentioned marks. We solved it. The EU CE certification covers the medical and civilian fields, EN14683 is a medical standard, and EN149 is a non-medical standard. American ASTM F2100 is a medical standard and is supervised by FDA; CFR42-84-1995 is a non-medical standard and has passed NIOSH certification. The summary is as follows: 1. The use of medical terms is prohibited; 2. The following executive standards should not appear: YY/T0969-2013, YY0469-2011, GB19083-2010 (these three are Chinese medical standards), EN14683, ASTM F2100; 3. For In the US market, it is strongly recommended not to display the FDA mark. Some FDAs will indirectly declare that it is medical. We cannot predict customs compliance standards. Export requirements for non-medical masks: 1 production company name (provide business license) 2 each package/small box product must have a certificate of conformity, implementation standards and production batches (manufacturer and production date are required above). It is not shown in the outer box, otherwise it will be regarded as a three-no product. 3 Product inspection report (manufacturing company) 4 For ordinary masks, the first is that the outer packaging cannot have Chinese and English medical words; the second is that the implemented national product standard is a non-medical standard; the third is that the product cannot carry the FDA or CE mark en14683. One of the words with the above words, standards and signs is medical masks. Attached copper mask implementation standard (incomplete) European implementation standard classification: EN-149 civil EN-143 civil EN-14683 medical national implementation standard; YY/T 0969-2013 disposable medical YY 0469-2011 medical GB 19083-2010 Civil GB/T32610 Civil GB/T2626-2006 Civil FDA Medical Mark
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