Product Name and Models(s):

COVID-19 IgM/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF BNCP-402

Classification: Other Device of IVDD 98/79/EC Conformity Assessment Route: IVDD 98/79/EC Annex III EDMA Code: 15 70 90 90 00

We herewith declare that the above mentioned products meet the transposition into national law, the provisions of the following EC Council Directives and Standards.

DIRECTIVES

General applicable directives:

DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 October 1998 on in vitro diagnostic medical devices

Standard Applied: EN ISO13485:2016, EN ISO14971:2012, EN 13975:2003, EN ISO 18113-1:2011, EN ISO 18113-2:2011, EN 13612:2002/AC:2002, EN ISO 17511:2003, EN ISO 23640:2015, EN ISO, EN 13641:2002, ISO 15223-1:2012

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