Manufacturer
ResMed
Australia, United StatesLegal entities : ResMed Corp., ResMed PTY LTD
Markets : France · Netherlands · Poland · United States
Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 137 · class I, II · latest in 2026 · see on the FDA website
Public contracts won : France 14 · Poland 3
EU representative : ResMed SAS (France)
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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