Document No.: CE-DOC-CG29-02 Rev.: 1/0 Manufacture Address: Beijing Lepu Medical Technology Co., Ltd. Building 7-1 No.37 Chaoqian Road, Changping District, Beijing, 102200, P.R. China European Representative: Lepu Medical (Europe) Cooperatief U.A. Abe...
More
Document No.: CE-DOC-CG29-02 Rev.: 1/0 Manufacture Address: Beijing Lepu Medical Technology Co., Ltd. Building 7-1 No.37 Chaoqian Road, Changping District, Beijing, 102200, P.R. China European Representative: Lepu Medical (Europe) Cooperatief U.A. Abe Lenstra Boulevard 36, 8448 JB, Heerenveen, The Netherlands Product information: 2019-nCoV Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) Model: 1 test/kit; 5 tests/kit; 10 tests/kit; 25 tests/kit; 50 tests/kit Classification: Others (not in List A and List B) GMDN code 64787 Conformity Assessment Route: Section 2 to 5 in annex III of IVDD 98/79/EC We herewith declare that the above mentioned products meet the provisions of the following EC Council Directives and Standards. All supporting documentations are retained under the premise of the manufacturer. This declaration of conformity is issued under the sole responsibility of the manufacturer (or installer). General Applicable Directive: DIRECTIVE 98/79/EC OF THE EUROPEAN PA
Less
