figfc NOXTEC NIPPON GASES NOXtec Development S.L. Calle Guadarrama 22, Moralzarzal, 28411-Madrid We, NOXTEC DEVELOPMENT SL, manufacturer SRN ES-MF-000009476, located in Guadarrama 22-24, Moralzarzal, 28411-Madrid, Spain, with a Quality Management System implemented in compliance with the requirements specified in EN ISO 13485:2016 standard, Declare under our sole responsibility, that the products/devices described in the following tables: Are in conformity with REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April Devices NOXtec 1000 and 2000 are classified as IIb in accordance with the rule 12 of the Annex VIII. Device NOXtec 3000 is classified as Im in accordance with the rule 13 of the Annex VIII. Are in conformity with the following standards: • UNE-EN 60601-1-6:2010/A2:2021 [Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance-Collateral standard: Usability] • UNE-EN 60601-1:2006/A2:2021 [Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Collateral standard- Electromagnetic disturbances - Requirements and tests]. • IEC 62304:2007/A1:2016 [Medical device software-Software life-cycle processes]. • UNE-EN 62366-1:2015/A1:2020 [Medical devices-Part 1: Application of usability engineering to medical devices]. • UNE-EN 61000-4-3:2020 [Electromagnetic compatibility [EMC]-Part 4-3: Testing and measurement techniques -Radiated. radiofrequency, electromagnetic field immunity test). • UNE- EN 61000-3-3:2013/A2:2022 [Electromagnetic compatibility [EMC]-Part 3-3: Limits -Limitation of voltage changes. voltage fluctuations and flicker in public low voltage supply systems for equipment with rated current <=16A per phase and not subject to conditional connection]. • UNE-EN 61000-4-11:2021/AC2022-10 [Electromagnetic compatibility [EMC] - Part 4-11: Testing and measurement techniques-Voltage dips, short interruptions and voltage variations immunity tests]. • UNE-EN 61000-4-4:2013 [Electromagnetic compatibility [EMC] - Part 4-4: Testing and measurement techniques -Electrical fast transient/burst immunity test]. • UNE-EN 61000-4-6:2014 [Electromagnetic compatibility [EMC] - Part 4-6: Testing and measurement techniques -Immunity to conducted disturbances, induced by radio-frequency fields]. • UNE-EN 61000-4-5:2015.A1:2018 [Electromagnetic compatibility [EMC] - Part 4-5: Testing and measurement techniques - Surge immunity test]. • UNE-EN 61000-4-8:2011 [Electromagnetic compatibility [EMC] - Part 4-8: Testing and measurement techniques -Power frequency magnetic field immunity test]. • UNE-EN 55011:2016/A2:2021 [Industrial, scientific and medical equipment - Radio- frequency disturbance characteristics -Limits and methods of measurements].

figfc NOXTEC NIPPON GASES NOXtec Development S.L. Calle Guadarrama 22, Moralzarzal, 28411-Madrid • IEC 60601-1-8:2007/A2:2021 [Medical electrical equipment Part 1-8: General requirements for basic safety and essential performance-Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment; and medical electrical systems). • UNE-EN 60601-1-2:2015/A1:2021 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests). • WEEE...