Identity
- Trade Name
- Arie Nasal Vented Mask, Medium EUDAMED
- Device Name
- Nasal Mask EUDAMEDFull Face Mask EUDAMED
- Model / Reference
- 50150 EUDAMED50805 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00814747024683 EUDAMED00814747024720 EUDAMED
- Basic UDI-DI
- 08147470220MT EUDAMED08147470219NA EUDAMED
- EMDN Code
- R0301010201 CPAP MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMEDNetherlands 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, Medium 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 | 08147470220MT | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sleepnet Corporation
- EUDAMED SRN
- US-MF-000010620
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (2)
- EUDAMED 8318a964-2ec2-4088-8975-9f07ec6bb2c3 61 fields · synced Jul 16, 2026
- EUDAMED 72e789bf-fc1d-487e-b3cf-a62ce666dd5e 61 fields · synced May 17, 2026