Identity
- Trade Name
- AIRSENSE 11 AUTOSET UK EUDAMEDAIRSENSE 11 AUTOSET UK TRI EUDAMED
- Device Name
- AirSense 11 AutoSet , AirSense 11 Elite EUDAMED
- Model / Reference
- 39172 EUDAMED39174 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00619498391721 EUDAMED00619498391745 EUDAMED
- Basic UDI-DI
- 619498EC19776 EUDAMED
- Direct Marketing DI
- 00619498394364 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 11 Autoset Uk 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 | 619498EC19776 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ResMed PTY LTD
- EUDAMED SRN
- AU-MF-000011753
- Authorised Representative
- ResMed SAS FR-AR-000007151
Sources (2)
- EUDAMED 9204f051-ad9f-42ce-8dbd-a4cdf25766f8 61 fields · synced Jul 30, 2026
- EUDAMED a3eafddc-0e69-4065-865e-0d16c7b1ae32 61 fields · synced May 16, 2026