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Conformity statement
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Conformity statement

Conformity statement
1 /1Page

Catalog excerpts

Conformity statement -1

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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