Ss 4 J ira E oc wi o ° °o a 4 *} ir = o rrr] co) Bd bE 4 3 Py e Ss - a wi Oo ° Bult i FI ZERTIFIKAT ® CERTIFICATE @ ix ener durct/Dengrted by etl der under & Z2UG-BS-244,10.08, EC Certificate Full Quality Assurance System Directive £3/42/EEC on Medical Devices (MDD), Annex II excluding (4) (Devices in Class ta, lb oF Il} No. G1 010815 0038 Rev. 01 Manufacturer: Fisher & Paykel Healthcare Ltd. 15 Maurice Paykel Place East Tamaki, Auckland 2013 NEW ZEALAND Product Category(ies): Respiratory Gas Delivery Systems, Heated Humidifiers, Continuous Positive Airway Pressure Units, Gas Powered Pulmonary Resuscitators, Nasal and/or Oral Interfaces for Delivery of Respiratory Gases, Patient Monitoring Software for Use with Fisher & Paykel Healthcare Medical Devices, Insufflation Gas Conditioning Systems ‘The Certification Body of TOV SUD Product Service GmbH deciares that the aforementioned ‘manufacturer has implemented a quality assurance system for design, manufacture and final inspection of the respective devices / device categories in accordance with MDD Annex Il. This quality assurance system conforms to the requirements of this Directive and is subject to periodical surveillance. For marketing of class Ill devices an additional Annex Il (4) certficate is mandatory. See also notes overleaf. Report No.: JAQ235040717 Valid from: 2019-12-42 Valid until: 2024-05-26 Date, 2019-12-42 0: Du Christoph Dicks Head of Certification/Notified Body Page 1 of 2 TOV SOD Product Service GmbH is Noted Body wit identification no. 0123 ‘TOV SUD Product Service GmbH « Ceriffcation Body + Ridlerstrae 65 - 80338 Munich + GermanyiS 4 re) rs e o rrr) o ° =) a 4 re) rs Ee o wi °o oa kb = = bY e Ss e o wi ce) a HO om Biche ZERTIFIKAT ® CERTIFICATE @ ix HAH y, senor drcDengrated by rete cer tncer KBE x Sefecimen re Rie A* — 716-25-244.10.08 EC Certificate Full Quality Assurance System Directive 83/42/EEC on Medical Devices (MDD), Annex Il excluding (4) (Devices in Class tla Ib or Il) No. G1 010815 0038 Rev. 01 kg) Proiue Senice ies): Fisher & Paykel Healthcare Ltd. ty(ies): 48 Maurice Paykel Place, East Tamaki, ‘Auckland 2013, NEW ZEALAND + Page 2 of 2 ‘TOV SUD Product Service GmbH is Notified Body with identification no. 0123 ‘TOV SOD Product Service GmbH « Certification Body « Ridlerstrae 65 + 80339 Munich » GermanyZertifiziervertrag Grundiage fur die Zertifikatserteilung ist die Priit- und Zertifizierordnung von TUV SUD Product Service. Mit Erhalt des Zertifikates erkennt der Zertiikatsinhaber die jeweils giltige Fassung der Priif- und Zertifizierordnung an (www.tuev- sued.de/ps_regulations) und wird somit Partner im Zertifiziersystem von TUV SUD Product Service. Certification contract . Certification is based on the TUV SUD Product Service Testing and Certification Regulations. On receipt of the certificate the certificate holder agrees to the current version of the Testing and Certification Regulations (www.tuv- sud.com/ps_regulations) and thus becomes partner, in the TUV SUD Product Service Certification System. Prinzipielle Voraussetzung fiir die Giiltigkeit des Zertifikates: © Gilltigkeit der zitierten normativen Priifgrundlage(n) ist gegeben und zusatzlich bei Zertifikaten mit Berechtigung zur Verwendung eines Prifzeichens bzw. bei Zertifikaten far QM-Systeme: ‘* Voraussetzungen fur vorschriftsmaBige Fertigung werden eingehalten. * Die Fertigungs- bzw. Betriebsstaitten werden regelmaBig dberwacht. Requirements for the validity of the certificate in principle: + Validity of the quoted test standard(s) In addition, for certificates with the right to use a certification mark and for QM certificates: * Conditions for an adequate manufacturing are maintained ‘+ Regular surveillance of the facility is performed uitaH WiERF TOV SUD FMS CURATED RATAMAKTRS HARES RAN (MRR UAiEEM) (JL www.tuv-sud.comips regulations ) HERA TUV SUD FP RMRBUERRAN SIKH. ORE ‘®aLIs TUV SUD Product Service DRAREAER AIC BI<. BEBREACREREBATSC CCK 1) SBS © BURRS REAR (www.tuv- sud.com/ps_regulations) IK IRLEEDE TS. TOR, TUV SUD Product Service REED AF ON-hF-ERS, Contrato de certificagao A certificacao se baseia nos Regulamentos de Testes e Certificagao do Grupo TUV SUD. ‘Ao receber 0 certificado, o Fornecedor, titular do cettificado concorda com a versao atual dos Regulamentos de Testes e Certificagdo do Grupo TUV SUD (www.tuv-sud.com/ps_regulations) e assim, torna-se parceiro no Sistema de Certificagao de Produtos e Servigos TUV SUD. BTR ARENRUER : ° ARE EAE J, ME BRT RAMEE OES MA EE MRED : © REED WEP RE ° SP See ERHee BERORMECNT SRMHTRREA ° BAL TUSRRRET MTHS a6 XA 7 OA ERE Nite! BNR XY NREERIS © HWCREORFEMEL TUS © EM HS IBSERE REL TUS SP ia Requisitos para a validade do certificado (em principio): * Validade da(s) norma(s) de ensaio(s) referenciada(s). Adicionalmente, para os certificados com o direito ao uso da marca de certificagao e para certificados de SG * Condigées de fabricagao adequada esto mantidas. * Auditoria de monitoragao realizada regularmente,