EC Certificate Full Quality Assurance System: Certificate GB20/965349 ‘The managerent syste of Penlon Limited ‘Abingdon Science Park, Barton Lane, Abingdon, Oxfordshire, OX14 3NB, UK Directive 93/42/EEC ‘on medical devices, Annex Il (excluding Section 4) Foto fotoving pros ‘The scope of registration appears on page 2 of this certificate. This certificate is valid from 01 December 2020 until 13 October 2023 and remains valid subject to satisfactory surveillance audits. Issue 6. Certified sinos 03 January 2017 and frst cerified by SGS Belglum NV since 28 February 2020 ‘Citcabn s based or prs manta GBIPC. 240535 orien by SGS Belgium NV, Notified Body 1639 SSS Houma Nordin 872000 Ane Belgium 1632 085 8.48 1-92 (0856548 4 NW scam Page fot Suct ra ‘This document is a Web version of SGS certificate for electronic use ‘xclusivaly.Itshall only bo avaliable by clicking on SGS Certification Mark ‘hich Nas been posted on Your Website shall not be printed in anyway, ‘This document is copyright protected. No content or appeerafice may be Tapreduced uithout the express written permission of SGS. Any misuse, slieration, forgery or falsification is unlawful rag & c Ze, S shCertificate GB20/965349 continued Penlon Limited Directive 93/42/EEC ‘on medical devices, Annex Il (excluding Section 4) Issue 6 Detaled scope Non-sterile anaesthesia and anaesthetic equipment, insufflation equipment, patient monitoring, oxygen therapy systems and medical hose assemblies. Oxygen therapy flowmeters & bubble humidifiers; AVS Ventilator, AVS MRI Ventilator & Nuffield 200 Ventilator; ‘Anaesthesia workstations with integrated ventilator - Prima 300 range: Prima 320 / Prima 830e / Prima 320 Advance | Prima 325/Prima 465, ‘Anaesthesia workstation Prima 400 series: Prima 440, Prima 445, Prima 450, Prima 451 MRI, Prima 460, Prima 465; ‘A200 SP Absorber & A200SP MRI Absorber for use as part ofa closed breathing system for anaesthesia; ‘Sigma EVA Vaporizer, Sigma Delta Vaporizer & Sigma Delta MRI Vaporizer forthe provision of accurate concentrations of the anaesthetic drugs into the fresh gas supply; Penion Oxygen Therapy Range to provide controlled flow cof humidified Oxygen to be administered to a patient: ‘AnaVue 4000 Patient Monitor ESO 2 Emergency Ventilator restricted forthe treatment of COVID-19 (SARS-CoV-2) Vivid Vue Patient Monitors range models: Vivid Vue 8, Vivid Vue 10 and Vivid Vue 12 ‘Appendix Page to note following devices: Class lla devices + Oxygen Therapy Flowmeters & Bubble Humidifiers *Modical Hose assemblies (Class ib devices + AVS Anaesthesia Ventilator and Accessories + AVS MRI Anaesthesia Ventilator and Accessories + Nuffield 200 Ventilator and accessories + Prima $20 Anaesthetic Machine and Accessories + Prima 320 Advance Anaesthetic Machine and Accessori + Prima 325 Anaesthetic Machine and Accessories + Prima 330e Anaesthetic Machine and Accessories + Prima 450 Anaesthetic Machine and Accessories + Prima 480 Anaesthotic Machine and Accessories + Prima 465 Anaesthesia Machine and Accessories. + Prima 440 Anaesthetic Machine and Accessories ‘This document is a Web version of SGS centficate for electronic use at ‘xclusivaly.Itshall only bo avaliable by clicking on SGS Cartifcation Mark ‘hich Nas been posted on Your Website shall not be printed in anyway, ‘This document is copyright protected. No content or appeeraiice may be ‘apreduced uithout the express written permission of SGS. Any misuse, slieration, forgery or falsification is unlawfulCortiticate GB20/965349 continued Penlon Limited Directive 93/42/EEC ‘on medical devices, Annex Il (excluding Section 4) Issue 6 Detaled scope + Prima 445 Anaesthetic Machine and Accessories + Prima 451 MRI Anaesthetic Machine and Accessories * A200SP Absorber and Accessories + A200SP MRI Absorber and Accessories + Sigma Delta Vaporizers and Accessories + Sigma Delta MRI Vaporizers and Accessories ‘Sigma EVA Vaporizer + AnaVue 4000 Patient Monitor and Accessories +ESO 2 Emergency Ventilator restricted for the treatment of COVID-19 (SARS-CoV-2), ‘Vivid Vue Patient Monitors range models: Vivid Vue 8, Vivid Vue 10 and Vivid Vue 12 and Accessorios Where the above scope Includes ats il medial device) valid EC Design Examination Cerificate ‘according to Annes I (Secton 4) andar requirement for ech device in adiion to this certicate to place that device onthe market ‘This document is a Web version of SGS centficate for electronic use ‘xclusivaly.Itshall only bo avaliable by clicking on SGS Cartifcation Mark ‘hich Nas been posted on Your Website shall not be printed in anyway, ‘This document is copyright protected. No content or appeeraiice may be ‘apreduced uithout the express written permission of SGS. Any misuse, slieration, forgery or falsification is unlawful