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Sign in to claim this brandRESMED PTY LTD
Australia·AU-MF-000011753
Last updated May 24, 2026
What RESMED PTY LTD makes
ResMed manufactures reusable 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 for respiratory therapy.
Their devices are classified as Class I, Class II, and Class IIa under regulatory frameworks and are listed in the EUDAMED and FDA UDI databases. The company is based in Australia.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does ResMed Pty Ltd manufacture?
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.
Where is ResMed Pty Ltd based?
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.
Which regulatory registries list ResMed’s devices?
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.
How are ResMed’s devices classified under regulatory frameworks?
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.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Australia
- Address
- 1, Elizabeth MacArthur Dr, Bella Vista, Australia
- Website
- resmed.com.au
- —
- —
- [email protected]
- Phone
- 800-424-0737
- PRRC Contact
- Xueling Zhu
- EUDAMED SRN
- AU-MF-000011753
- FDA FEI Number
- —
- DUNS Number
- 751149311
Catalogue (1078)
Page 11 of 22| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Nv Ultra Mirage | 60404 | FDA UDI | Class I | Active |
| Airfit N20 | 16142 | FDA UDI | Class II | Active |
| Stellar | 150 | FDA UDI | Class II | Active |
| AIRFIT P30i | 63850 | FDA UDI | Class II | Active |
| Um Ffm | 60669 | FDA UDI | Class II | Active |
| AcuCare | F1-4 | FDA UDI | Class II | Active |
| Astral | 27943 | FDA UDI | Class II | Unknown |
| Tx Link | 25927 | FDA UDI | Class II | Active |
| Ultra Mirage Ii | 16591 | FDA UDI | Class II | Active |
| Airfit F20 | 63473 | FDA UDI | Class II | Active |
| Mirage Softgel | 61622 | FDA UDI | Class II | Active |
| Astral | 29141 | FDA UDI | Class II | Active |
| AirTouch F20 | 63032 | FDA UDI | Class II | Active |
| Airfit N20 | 63554 | FDA UDI | Class II | Active |
| Mirage Liberty | 61360 | FDA UDI | Class II | Active |
| Air 11 | 39303 | FDA UDI | Class II | Active |
| Swift Lt | 60583 | FDA UDI | Class II | Active |
| AIRFIT P30i | 63863 | FDA UDI | Class II | Active |
| Autoset | 30919 | FDA UDI | Class II | Active |
| Um/Umii | 16560 | FDA UDI | Class II | Active |
| AirTouch N30I | 62313 | FDA UDI | Class II | Active |
| Aircurve | 37412 | FDA UDI | Class II | Active |
| Nv Quattro Air | 62781 | FDA UDI | Class I | Active |
| Mirage Swift Ii | 60543 | FDA UDI | Class II | Active |
| Airfit F 10 | 63164 | FDA UDI | Class II | Active |
| ClimateLineAir 11 Oxy | 39232 | FDA UDI | Class II | Active |
| Airfit F 10 | 63160 | FDA UDI | Class II | Active |
| Mirage Fx | 62125 | FDA UDI | Class II | Active |
| AcuCare | F1-0 | FDA UDI | Class I | Active |
| Airsense | 37210 | FDA UDI | Class II | Active |
| AirMini | 38843 | FDA UDI | Class II | Active |
| S9 | 36950 | FDA UDI | Class II | Active |
| Activa/Umffm | 60116 | FDA UDI | Class II | Active |
| Airfit F30i | 63372 | FDA UDI | Class II | Active |
| Airfit F20 | 63461 | FDA UDI | Class II | Active |
| Um Ffm | 16509 | FDA UDI | Class II | Active |
| Airtouch N30i | 62306 | FDA UDI | Class II | Active |
| Tx Link | 25101 | FDA UDI | Class II | Active |
| AIRFIT P30i | 63854 | FDA UDI | Class II | Active |
| Quattro Air | 62755 | FDA UDI | Class II | Active |
| Mirage Quattro | 61275 | FDA UDI | Class II | Active |
| Mirage Quattro | 61296 | FDA UDI | Class II | Active |
| AIRFIT N30i | 63803 | FDA UDI | Class II | Active |
| Mirage Swift | 60551 | FDA UDI | Class II | Active |
| ResScan | 31332 | FDA UDI | Class II | Active |
| Swift Lt | 60579 | FDA UDI | Class II | Active |
| Airfit P 10 | 62936 | FDA UDI | Class II | Active |
| Airfit N20 | 63539 | FDA UDI | Class II | Active |
| Resmed | 24976 | FDA UDI | Class II | Active |
| AirTouch N20 | 63954 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
- ResMed SAS FR
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