Identity
- Trade Name
- AIRFIT F20 NON MAGN SML QUIET-EU EUDAMED
- Device Name
- AirTouch F20 and AirTouch F20 For Her,AirFit F20 Quiet and AirFit F20 For Her Quiet,AirFit F20 and AirFit F20 For Her,AirFit F20 Non Magnetic EUDAMED
- Model / Reference
- 64031 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00619498640317 EUDAMED
- Basic UDI-DI
- 619498EC1726N EUDAMED
- Direct Marketing DI
- 00619498004102 EUDAMED
- EMDN Code
- R0301010201 CPAP MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Airfit F20 Non Magn Sml Quiet-Eu by Resmed Pty Ltd — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K153563 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K170924 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 619498EC1726N | Class IIa | Active |
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Manufacturer
- Manufacturer
- ResMed PTY LTD
- EUDAMED SRN
- AU-MF-000011753
- Authorised Representative
- ResMed SAS FR-AR-000007151
Sources (2)
- EUDAMED 24b84fb4-f46a-4d38-8e0c-336867c3f224 61 fields · synced Oct 6, 2026
- FDA 510(k) K153563 1 fields · synced May 18, 2026