Identity
- Trade Name
- AirFit P10 for Her SYS - EUR3 EUDAMED
- Device Name
- AirFit P10 and AirFit P10 For Her EUDAMED
- Model / Reference
- 62913 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00619498629138 EUDAMED
- Basic UDI-DI
- 619498EC1426D EUDAMED
- Direct Marketing DI
- 00619498004089 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 P10 for Her SYS - EUR3 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 | 619498EC1426D | 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 (1)
- EUDAMED ef9da0ba-bf0d-4192-a79d-42e585ef0bf8 61 fields · synced Jul 22, 2026