Question 1

What types of medical devices does ResMed Pty Ltd manufacture?

Accepted Answer

ResMed Pty Ltd specializes in reusable respiratory therapy devices. Their product range includes CPAP and BPAP face and nasal masks, home CPAP and BPAP units, portable electric ventilators, heated respiratory humidifiers, ventilator breathing circuits, and heat/moisture exchanger filters. These devices are designed to support patients with sleep apnea, chronic obstructive pulmonary disease (COPD), and other respiratory conditions.

Question 2

Where is ResMed Pty Ltd based?

Accepted Answer

ResMed Pty Ltd is headquartered in Australia. The company’s location influences its regulatory compliance, particularly for devices marketed in the EU and other regions, where local manufacturing or distribution may impact classification and listing requirements.

Question 3

Which regulatory registries list ResMed’s devices?

Accepted Answer

ResMed’s devices are listed in the EUDAMED database for European Union regulatory transparency and the FDA UDI (Unique Device Identifier) database for the United States. These registries help healthcare providers and regulators track device details, compliance, and market history.

Question 4

How are ResMed’s devices classified under regulatory frameworks?

Accepted Answer

ResMed’s devices fall under Class I, Class II, and Class IIa classifications. Class I devices generally pose minimal risk (e.g., reusable masks), while Class II and Class IIa devices (like ventilators or humidifiers) involve higher risk and require stricter regulatory oversight to ensure safety and performance. Classification determines labeling, post-market surveillance, and compliance requirements.

Device	Model / Reference	Registries	Class	Status
Airsense 10 Autoset Fh Edn	37420	EUDAMED	Class IIa	Active
AirCurve 10 VAuto FR	37238	EUDAMED	Class IIa	Active
AirCurve 10 CS PaceWave NORD	37281	EUDAMED	Class IIa	Active
AirCurve 10 S DE CO	37251	EUDAMED	Class IIa	Active
Stellar 130 Germany	24172	EUDAMED	Class IIb	Active
Aircurve 11 Asv Pacewave Nord Tri	39185	EUDAMED	Class IIa	Active
Airfit F20 For Her Med Quiet-Eu1	64009	EUDAMED	Class IIa	Active
Lumis 100 VPAP S UK/EUR2 TRI	28003	EUDAMED	Class IIa	Active
H4i for Stellar EUR GP 2	24930	EUDAMED	Class IIa	Active
NV Quattro Air FFM MED - EUR	62784	EUDAMEDFDA UDI	Class IIa	Active
Aircurve 10 Cs-A Pacewave Ger Co	28283	EUDAMED	Class IIa	Active
Airsense 10 Elite Uk	37424	EUDAMED	Class IIa	Active
AirSense 10 AutoSet EastEU	37271	EUDAMED	Class IIa	Active
Lumis 150 VPAP ST FR	28111	EUDAMED	Class IIa	Active
Gecko Nasal Pad Sml - Row	61912	EUDAMED	Class I	Active
Airfit F20 For Her Sml - Eu1	63408	EUDAMED	Class IIa	Active
Stellar 150 France	24142	EUDAMED	Class IIb	Active
Chin Restraint	16015	EUDAMEDFDA UDI	Class I	Active
Airfit N30i Sys W/Std Quiet Eu	63820	EUDAMED	Class IIa	Active
AirSense 11 AutoSet CH TRI	39191	EUDAMED	Class IIa	Active
AirFit P10 Mask SYSTEM - EUR2	62902	EUDAMED	Class IIa	Active
RPSII - Battery Coupler Kit	24964	EUDAMEDFDA UDI	Class I	Active
AirSense 10 AutoSet DE NO CAM	37496	EUDAMED	Class IIa	Active
Airfit N30 Mask Sys Eu	64204	EUDAMED	Class IIa	Active
AirCurve 10 VAuto DE CO	37249	EUDAMED	Class IIa	Active
Lumis 150 VPAP ST UK/EUR2	28115	EUDAMED	Class IIa	Active
Lumis 150 VPAP ST EUR3 CO	28116	EUDAMED	Class IIa	Active
Airfit F20 For Her Med Quiet-Eu4	64014	EUDAMED	Class IIa	Active
Lumis 150 Vpap St-A Fr Co	28216	EUDAMED	Class IIa	Active
NV Quattro Air FFM XSML - EUR	62782	EUDAMEDFDA UDI	Class IIa	Active
RPS II- Stellar 0.5m DC Cable	24981	EUDAMEDFDA UDI	Class I	Active
Airsense 11 Autoset Uk Co	39173	EUDAMED	Class IIa	Active
Stellar 150 UK	24145	EUDAMED	Class IIb	Active
Airsense 11 Autoset Eu Tri	39152	EUDAMED	Class IIa	Active
AirSense 10 AutoSet DE CO	37246	EUDAMED	Class IIa	Active
Airfit F20 Med Sys Quiet-Eu4	64011	EUDAMED	Class IIa	Active
CPAP Mask Wipes Box 14 sachets	61919	EUDAMED	Class I	Active
Airfit F20 For Her Sml Quiet-Eu4	64013	EUDAMED	Class IIa	Active
Airsense 11 Autoset Uk	39172	EUDAMED	Class IIa	Active
Airfit F20 Lge Sys - Eu1	63407	EUDAMED	Class IIa	Active
Airfit F30i Non Magnet W/Std-Eu	63344	EUDAMED	Class IIa	Active
AirCurve 10 ST DE	37348	EUDAMED	Class IIa	Active
Airfit F20 Med Sys Quiet-Eu1	64006	EUDAMED	Class IIa	Active
Aircurve 11 Vauto Nord Tri	39183	EUDAMED	Class IIa	Active
Airfit F40 Std Stpk -slm Eu1	64624	EUDAMED	Class IIa	Active
Airfit F40 Sys - L/Std Multih Eu1	64622	EUDAMED	Class IIa	Active
AirSense 10 AutoSet FR CO	37237	EUDAMED	Class IIa	Active
AirSense 10 Elite FR CO	37235	EUDAMED	Class IIa	Active
AirSense 10 AutoSet CH TRI	37274	EUDAMED	Class IIa	Active
Airfit F30i Non Magnet S/Std-Eu	63342	EUDAMED	Class IIa	Active

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