3150422_ADDITIONAL_211029-ENG-IVD-Schnelltest-Art.3150422-Hangzhou Biotest Biotech

1. EC Declaration of Conformity Manufacturer: Name ： HANGZHOU BIOTEST BIOTECH CO., LTD Address : No. 17, Futai Road, Zhongtai Street, Yuhang District, Hangzhou - 311121 P.R. China European Representative: Name: Shanghai International Holding Corp. GmbH (Eur ope) Address: Eiffestrasse 80, 20537 Hamburg, Germany Product Name: COVID - 19 Antigen Rapid Test Cassette (Nasal Swab) Catalog Number: IC OVN - C81H ( Brand Name: RightSign, ExactSign ) 302282( Brand Name: Sienna ) Classification: Annex II, Self - test ing Device of IVDD 98/79/EC Conformity Asses sment Route: IVDD 98/79/EC Annex I II section 6 We herewith declare that the above mentioned products meet the transposition into national law, the provisions of the following EC Council Directives and Standards. All supporting documentations are retained under the premises of the manufacturer. Hangzhou Biotest takes exclusive responsibility for this declaration of conformity. 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 ISO 13485:2016, EN ISO14971:2012, EN ISO 18113 - 1:2011, EN ISO 18113 - 4:2011, EN 13612:2002/AC:2002, EN13532:2002, EN ISO 17511:2003, EN ISO 15193:2009, EN ISO 15223 - 1:2016, EN ISO 15194:2009, EN ISO 236 40:2015, EC 1272/2008 Notified Body ： Name ： POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. Address ： ul. Puławska 469 02 - 844 Warszawa Poland Identification number: CE 1434 (EC) Certificate(s): 1434 - IVDD - 455/2021 Expire date of the Certificate: 2024 - 05 - 27 Start of CE Marking: 2021 - 09 - 01 Place, Date of Issue: Hangzhou, P.R. China, Oct. 29 , 2021 Signature: Name : Super Liu Position : Quality Director EC DECLARATION OF CONFORMITY EC DECLARATION OF CONFORMITY