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Conformity statement (standard elbow)

Conformity statement (standard elbow)

Product catalog summary
Declaration of Conformity Overview
Manufacturer and Representatives: The document is issued by ResMed Pty. Ltd., located in Australia, with ResMed SAS in France as the authorized representative. The notified body involved is TÜV SÜD Product Service GmbH in Germany.
Product Details: The declaration pertains to the AirFit F20 and AirFit F20 For Her mask systems. These are non-invasive accessories designed to channel airflow from devices like CPAP or bilevel systems to patients.
Intended Use: The masks are intended for patients over 66 lb (30 kg) who require positive airway pressure therapy. They are suitable for single-patient reuse at home and multi-patient reuse in hospital settings.
Classification and Compliance: The product is classified as Class IIa under Rule 2, with EMDN code R0301010201 for CPAP masks. The conformity assessment follows Annex IX of Regulation EU 2017/745, excluding Chapter II. The Basic UDI-DI is 619498EC1726N.
Regulatory Compliance: The products conform to Council Regulation 2017/745 for medical devices, with compliance effective from the date specified. Supporting documentation is maintained by the manufacturer.
Certification and Signatory: The EC Certificate Number is G15 049861 0261 Rev. 01, and the SRN is AU-MF-000011753. The declaration is signed by Nicole Wilson, the Person Responsible for Regulatory Compliance at ResMed Pty. Ltd., on 18 February 2026.
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Catalog excerpts

Conformity statement (standard elbow)-1

Declaration of Conformity Manufacturer: Authorized Representative: Notified Body: ResMed Pty. Ltd. 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia ResMed SAS Parc Technologique de Lyon 292 Allée Jacques Monod 69791 Saint Priest Cedex France TÜV SÜD Product Service GmbH Ridlerstraße 65 80339 München Germany Product: AirFit F20 and AirFit F20 For Her Intended Use: The AirFit F20 / AirFit F20 For Her Mask System is a non-invasive accessory used for channelling air-flow (with or without supplemental oxygen) to a patient from a positive airway pressure device such as Continuous Positive Airway Pressure (CPAP) or bilevel system. The AirFit F20 / AirFit F20 For Her Mask System is: • to be used by patients (weighing >66 lb/30 kg) for whom positive airway pressure therapy has been prescribed. • intended for single patient re-use in the home environment and multi-patient re-use in the hospital/institutional environment. Classification: IIa according to Rule 2 EMDN: R0301010201 CPAP Masks Conformity Assessment Route: Annex IX (excluding Chapter II), Regulation EU 2017/745 Basic UDI-DI: 619498EC1726N Common Specification: N/A We herewith declare that the above mentioned products are in conformity with the Council Regulation 2017/745 for medical devices. Compliance is applicable from the date listed below. All supporting documentation is retained at the premises of the manufacturer. This declaration is issued under the sole responsibility of ResMed Pty. Ltd. EC Certificate Number: G15 049861 0261 Rev. 01 SRN: AU-MF-000011753 Signed at Sydney, Australia on: 18 February 2026 Nicole Wilson Person Responsible for Regulatory Compliance (PRRC) ResMed Pty. Ltd. EC172a.1 First issued: 28 Februar

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