Identity
- Trade Name
- Arie Nasal Vented Mask Kit EUDAMED
- Device Name
- Full Face Mask EUDAMEDNasal Mask EUDAMED
- Model / Reference
- 50851 EUDAMED50194 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00814747024744 EUDAMED00814747024706 EUDAMED
- Basic UDI-DI
- 08147470219NA EUDAMED08147470220MT 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
Arie Nasal Vented Mask Kit by Sleepnet Corporation — 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 | 08147470219NA | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sleepnet Corporation
- EUDAMED SRN
- US-MF-000010620
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (2)
- EUDAMED 89d16c55-f11e-4b33-bf94-c91327e25710 61 fields · synced Aug 3, 2026
- EUDAMED 2b536644-a980-495f-9861-c7faaa85297b 61 fields · synced May 18, 2026