Conformity statement

Product catalog summary

Declaration of Conformity Overview

This document is a Declaration of Conformity for the AirFit F20 Non-Vented full face mask, issued by ResMed Pty. Ltd. It confirms compliance with the Council Directive 93/42/EEC for medical devices, including the MDD amendment 2007/47/EC.

Representative and Signatories

The declaration is issued under the sole responsibility of ResMed Pty. Ltd., with Johanna Wright, Director of Regulatory Affairs, as the signatory. The document was signed in Sydney, Australia, on 21 May 2021.

Product Description

The AirFit F20 Non-Vented full face mask is designed for non-invasive positive pressure ventilation. It serves as an accessory to ventilators with adequate alarms and safety systems for ventilator failure. The mask is intended for patients weighing more than 30 kg and is suitable for single-patient re-use at home or multi-patient re-use in hospital settings.

Conformity Assessment and Certification

The product follows the conformity assessment route IIa according to Rule 2 and is classified under GMDN code 57814 as a CPAP/BPAP face mask, reusable. The conformity assessment was conducted by TÜV SÜD Product Service GmbH, with the EC Certificate Number G1 049861 0158.

Standards and Regulations

The product complies with Annex II (excluding Section 4) of the 93/42/EEC directive. The notified body involved in the conformity assessment is identified by the number 0123.

Catalog excerpts

Notified Body: ResMed Pty. Ltd. 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia ResMed SAS Pac Technologique de Lyon 292 Allée Jacques Monod 69791 Saint Priest Cedex France TÜV SÜD Product Service GmbH Ridlerstraße 65 80339 München Germany The AirFit F20 Non-Vented full face mask is a patient interface to deliver non-invasive positive pressure ventilation. It is intended to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure, to administer continuous or intermittent ventilatory support. The AirFit F20 Non-Vented full face mask is: • to be used by patients weighing more than 30 kg • intended for single-patient re-use in the home environment and/or multi-patient re-use in the hospital/institutional environment. 57814 CPAP/BPAP face mask, reusable ConformityAssessment Route: Annex II (excluding Section 4), 93/42/EEC We herewith declare that the above mentioned products are in conformity with the Council Directive 93/42/EEC for medical devices including the MDD amendment 2007/47/EC. &RPSOLDQFHLVDSSOLFDEOHIURPWKHGDWHOLVWHGEHORZ$OOVXSSRUWLQJGRFXPHQWDWLRQLVUHWDLQHGDWWKH SUHPLVHVRIWKHPDQXIDFWXUHU This declaration is issued under the sole responsibility of ResMed Pty. Ltd. EC Certificate Number: G1 049861 0158 Signed at Sydney, Australia on: 21 May 2021 __________________________________________ Johanna Wright Director of Regulatory Affairs ResMed Pty. Ltd.

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