Identity
- Trade Name
- AIRFIT F20 SML SYS QUIET-EU1 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
- 64005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00619498640058 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 Sml Sys Quiet-Eu1 by Resmed Pty Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- EUDAMED ede95c57-fe19-4ff6-beed-3c0b5e3f4b1d 61 fields · synced Jul 31, 2026