8320 declaration of conformity

1. VERSION 1.0.0 | 210629_SB | PAGE 1/1 Kreissparkasse Köln Sparkasse Köln/Bonn HypoVereinsbank IBAN: BIC: DE49 3705 0299 0127 2721 64 COKSDE33XXX IBAN: BIC: DE32 3705 0198 1933 3245 90 COLSDE33XXX IBAN: BIC: DE63 3702 0090 0027 7497 39 HYVEDEMM429 Es gelten unsere allgemeinen Geschäfts- und Lieferbedingungen (zu finden unter www.nitras.de oder auf Anfrage). Our general terms and conditions of business and delivery apply (can be found at www.nitras.de or on request). MCD Medical Care Dental GmbH | Heinrich-Hertz-Str. 11 | 50181 Bedburg | Germany | Geschäftsführer / Managing Director: Maria Baric, Markus Seiler | HRB 83971 | Gerichtsstand Köln | USt.-IdNr.: DE299692222 +49 2272 401 111 +49 2272 401 200 info@nitras-medical.com www.nitras-medical.com EN DECLARATION OF CONFORMITY MCD Medical Care Dental GmbH Heinrich-Hertz-Str. 11 50181 Bedburg Germany hereby declares that article 8320 // BLACK WAVE 2008320 // BIG BLACK WAVE complies with Regulation (EC) No. 1935/2004 and Regulation (EC) No. 2023/2006 as amended. Specification to the intended use or limitations: Type(s) of food to be in contact with the material: All (no restrictions) Conditions of use, such as duration and temperature of treatment or storage in contact with the food: Two hours at 40°C Ratio of the area in contact with foodstuffs to the volume on the basis of which the conformity of the material or article was established: 6 dm 2 / 1 kg food No functional barrier is used. MCD Medical Care Dental GmbH Bedburg, 29.06.2021 Signed for and on behalf of: Maria Baric, Management Board NAME, FUNCTION SIGNATURE PLACE AND DATE OF ISSUE