Identity
- Trade Name
- AirSense 10 Elite FR CO EUDAMEDAirSense 10 Elite FR EUDAMED
- Device Name
- AirSense 10 AutoSet , AirSense 10 Elite , AirSense 10 AutoSet For Her , AirSense 10 AutoSet No CAM (C2C) EUDAMED
- Model / Reference
- 37235 EUDAMED37234 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00619498372355 EUDAMED00619498372348 EUDAMED
- Basic UDI-DI
- 619498EC1496T EUDAMED
- Direct Marketing DI
- 00619498371242 EUDAMED
- EMDN Code
- Z12030102 CONTINUOUS POSITIVE PRESSURE EQUIPMENT 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
Yes
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
AirSense 10 Elite FR CO 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 | 619498EC1496T | 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 d3a32ff6-99e9-40f3-ad0b-5d20bc6fd894 61 fields · synced Jul 11, 2026
- EUDAMED 8a3a2557-7f9e-480b-a0ea-32f0c25696b4 61 fields · synced May 17, 2026