EC DECLARATION OF CONFORMITY Manufacturer OXYCARE PREFABRİK MOBİL ÇÖZÜMLER SANAYİ İTHALAT İHRACAT TİCARET LİMİTED ŞİRKETİ Address HEAD OFFICE: BÜYÜKŞEHİR MAH. BEYLİKDÜZÜ CAD. NO: 5 /2 İÇ KAPI NO:60 BEYLİKDÜZÜ / İSTANBUL / TÜRKİYE FACTORY: ÇERKEŞLİ OSB MAH. IMES-18 CAD. KÜÇÜK SAN. SİT. B9 BLOK NO:9/2 DİLOVASI / KOCAELİ / TÜRKİYE Statement It has been accepted by the company that the applicable requirements of the (EU) 2017/745 (MDR) Medical Devices Regulation have been fulfilled and the responsibility has been taken for the products with the following definitions. The products with the following definitions have been checked that the internal production controls are carried out by the organization. If there is a change in the product, this declaration will not be accepted and will lose its validity. Description of Product HYPERBARIC OXYGEN CABINET Product Brand Directive and Regulation (EU) 2017/745 (MDR) Medical Devices Regulation Harmonized Standards EN ISO 13485:2016, EN ISO 14971:2019, EN ISO 15223-1:2016, EN 62366-12015/AC 2016-09, EN ISO 62366-2:2016, EN ISO 62304/A1:2016, EN ISO 12100:2014, EN ISO 60601-1:2015+AMD1:2012+AMD2:2020, EN ISO 60601-1/A1:2017, EN ISO 60601-1-2:2016, EN ISO 14931:2006 CERTIFICATE NUMBER: IDS.CE.2023.19142 Certificate Date : 02.05.2023 Validity Date : 02.05.2024 International Documenting System Doo. Budva / Montenegro