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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 17 of 22| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Airfit F 10 | 63167 | FDA UDI | Class II | Active |
| Mirage Swift Ii | 60554 | FDA UDI | Class II | Active |
| AirView | 4.2 | FDA UDI | Class II | Active |
| AirFit F30 | 64140 | FDA UDI | Class II | Active |
| Mirage Micro | 16383 | FDA UDI | Class II | Active |
| Mirage Softgel | 61626 | FDA UDI | Class II | Active |
| Mirage Ffm | 16671 | FDA UDI | Class II | Active |
| Swift Lt | 60587 | FDA UDI | Class II | Active |
| AcuCare | 60791 | FDA UDI | Class II | Active |
| Nv Ultra Mirage | 60401 | FDA UDI | Class I | Active |
| Mirage Quattro | 61203 | FDA UDI | Class II | Active |
| Mirage Fx | 62129 | FDA UDI | Class II | Active |
| Mirage Swift | 60525 | FDA UDI | Class II | Active |
| Mirage Quattro | 61202 | FDA UDI | Class II | Active |
| Airfit N20 | 63535 | FDA UDI | Class II | Active |
| Swift Fx | 61530 | FDA UDI | Class II | Active |
| Apnealink | 22354 | FDA UDI | Class II | Active |
| Nv Ultra Mirage | 60405 | FDA UDI | Class I | Active |
| Humidx Plus | 38812 | FDA UDI | Class I | Active |
| Mirage Fx | 62112 | FDA UDI | Class II | Active |
| Airfit N20 | 63555 | FDA UDI | Class II | Active |
| Airfit N20 | 63537 | FDA UDI | Class II | Active |
| Swift Fx | 61510 | FDA UDI | Class II | Active |
| Um/Umii | 16566 | FDA UDI | Class II | Active |
| Swift Fx | 61523 | FDA UDI | Class II | Active |
| Mirage Liberty | 61320 | FDA UDI | Class II | Active |
| Mirage Activa | 60102 | FDA UDI | Class II | Active |
| Activa/Umffm | 60123 | FDA UDI | Class II | Active |
| S8 | 33919 | FDA UDI | Class II | Active |
| S9 | 36000 | FDA UDI | Class II | Active |
| Mirage Activa Lt | 60149 | FDA UDI | Class II | Active |
| Quattro Fx | 62505 | FDA UDI | Class II | Active |
| Swift Lt | 60588 | FDA UDI | Class II | Active |
| AirFit X30i | 64356 | FDA UDI | Class II | Active |
| Full Face | 16613 | FDA UDI | Class II | Active |
| AirFit N20 | 63503 | FDA UDI | Class II | Active |
| Resscan | 22915 | FDA UDI | Class II | Active |
| RPS II - Air 10 DC Cable | 37343 | EUDAMEDFDA UDI | Class I | Active |
| AirCurve 10 S DE | 37250 | EUDAMED | Class IIa | Active |
| AirSense 10 AutoSet FH NORD TRI | 37260 | EUDAMED | Class IIa | Active |
| AirCurve 10 CS PaceWave DE CO | 37278 | EUDAMED | Class IIa | Active |
| Airfit F30i Non Magnet M/Std-Eu | 63343 | EUDAMED | Class IIa | Active |
| Airfit F20 Med Sys - Eu3 | 63416 | EUDAMED | Class IIa | Active |
| AirFit P10 for Her SYS - EUR1 | 62911 | EUDAMED | Class IIa | Active |
| Airfit F40 Sys - M/Std Eu2 | 64674 | EUDAMED | Class IIa | Active |
| AirSense 11 AutoSet WE | 39140 | EUDAMED | Class IIa | Active |
| AirCurve 10 CS PaceWave CH | 37279 | EUDAMED | Class IIa | Active |
| Airfit F20 Med Sys - Eu1 | 63406 | EUDAMED | Class IIa | Active |
| Humidair11 Cleanable Row | 39112 | EUDAMED | Class IIa | Active |
| Airfit F20 Lge Sys Quiet-Eu1 | 64007 | EUDAMED | Class IIa | Active |
Related Companies
Authorised Representatives
- ResMed SAS FR
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