Identity
- Trade Name
- AIRTOUCH N30I M/SML QUIET EU EUDAMED
- Device Name
- AirFit N30i,AirFit P30i,AirTouch N30i EUDAMED
- Model / Reference
- 62343 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00619498623433 EUDAMED
- Basic UDI-DI
- 619498EC1816P EUDAMED
- Direct Marketing DI
- 00619498004126 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
Airtouch N30i M/Sml Quiet Eu 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 | 619498EC1816P | 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 4d6a9b8d-5702-43b1-a23c-ddff10f3836b 61 fields · synced Jun 19, 2026