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
Airfit F20 For Her Sml Quiet-Eu1	64008	EUDAMED	Class IIa	Active
Stellar 150 Europe Grp1	24143	EUDAMED	Class IIb	Active
AirCurve 10 VAuto DE	37248	EUDAMED	Class IIa	Active
AirCurve 10 ST DE CO	37349	EUDAMED	Class IIa	Active
Airfit F20 Med Sys - Eu2	63411	EUDAMED	Class IIa	Active
Air 10 USB Module	37301	EUDAMEDFDA UDI	Class I	Active
Lumis 150 Vpap St-A Ger	28222	EUDAMED	Class IIa	Active
AirFit P10 for Her SYS - EUR3	62913	EUDAMED	Class IIa	Active
Airfit F40 Sys - L/Std Eu2	64675	EUDAMED	Class IIa	Active
Airfit F30i Sys - M/Lge - Eu	63314	EUDAMED	Class IIa	Active
AirSense 11 Elite WE CO	39143	EUDAMED	Class IIa	Active
Lumis 100 VPAP ST UK/EUR2	28104	EUDAMED	Class IIa	Active
Airfit F40 Sys - M/Sml Multih Eu1	64623	EUDAMED	Class IIa	Active
Airsense 10 Autoset We C2c	37503	EUDAMED	Class IIa	Active
Aircurve 11 St De	39166	EUDAMED	Class IIa	Active
Airsense 10 Autoset Fh Uk	37430	EUDAMED	Class IIa	Active
AirCurve10 VAuto NORD TRI	37262	EUDAMED	Class IIa	Active
AirSense 10 Elite NORD	37256	EUDAMED	Class IIa	Active
AirSense 10 Elite MENA CO	37371	EUDAMED	Class IIa	Active
Stellar 100 - UK	24155	EUDAMED	Class IIb	Active
Airsense 10 Elite Czech Tri	37425	EUDAMED	Class IIa	Active
AirSense 10 AutoSet CH	37273	EUDAMED	Class IIa	Active
AirSense 10 AutoSet MENA CO	37372	EUDAMED	Class IIa	Active
Lumis 100 Vpap St-A Eur2	28221	EUDAMED	Class IIa	Active
Stellar 100 - France	24152	EUDAMED	Class IIb	Active
AirSense 11 Elite DE	39162	EUDAMED	Class IIa	Active
H4i for Stellar EUR GP 1, UK	24929	EUDAMED	Class IIa	Active
Airfit F20 Non Magn Lge Quiet-Eu	64033	EUDAMED	Class IIa	Active
Astral Trolley	27914	EUDAMEDFDA UDI	Class I	Active
AirSense 10 AutoSet UK	37254	EUDAMED	Class IIa	Active
AirCurve 10 CS PaceWave FR CO	37276	EUDAMED	Class IIa	Active
Airtouch N30i L/Std Quiet Eu	62341	EUDAMED	Class IIa	Active
AirSense 10 AutoSet FH CH TRI	37390	EUDAMED	Class IIa	Active
AirFit N30i SYS M/STD MultiH EU	63882	EUDAMED	Class IIa	Active
Airfit F20 For Her Med - Eu1	63409	EUDAMED	Class IIa	Active
Airsense 10 Autoset Edn C2c	37504	EUDAMED	Class IIa	Active
Airfit N30 Mask Sys Multihole Eu	64205	EUDAMED	Class IIa	Active
AirCurve 10 CS PaceWave NORD TRI	37282	EUDAMED	Class IIa	Active
Airtouch F20 Lge Sys - Eu	63036	EUDAMED	Class IIa	Active
Airsense 11 Autoset Cze Tri	39187	EUDAMED	Class IIa	Active
AirSense 10 AutoSet NORD	37258	EUDAMED	Class IIa	Active
AirCurve 10 S EDN	37351	EUDAMED	Class IIa	Active
Airfit F20 For Her Sml - Eu3	63418	EUDAMED	Class IIa	Active
Txlink 2 Eu	22402	EUDAMED	Class I	Active
Airfit F40 Sys - Sw/Std Eu1	64614	EUDAMED	Class IIa	Active
Airfit F40 Sys M/Std Multih Eu2	64680	EUDAMED	Class IIa	Active
Air 10 Oximetry Module	37302	EUDAMEDFDA UDI	Class I	Active
Airfit F20 Lge Sys - Eu2	63412	EUDAMED	Class IIa	Active
Airtouch F20 Med Sys - Eu	63035	EUDAMED	Class IIa	Active
Air11 Filter, Hypo, 2 Pack	39305	EUDAMEDFDA UDI	Class IIa	Active

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