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M AF531 SE NE W/CapStrap, SU, 10 Pack
EUDAMEDClass IIa (EU MDR)
Ref 1100397Model AF531 Oro-Nasal Mask with Nebulizing Elbow
Identity
- Trade Name
- M AF531 SE NE W/CapStrap, SU, 10 Pack EUDAMED
- Model / Reference
- AF531 Oro-Nasal Mask with Nebulizing Elbow EUDAMED1100397 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 30606959007346 EUDAMED
- Basic UDI-DI
- B-30606959007346 EUDAMED
- EMDN Code
- R0301010201 CPAP MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
M AF531 SE NE W/CapStrap, SU, 10 Pack by Respironics, Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-30606959007346 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Respironics Deutschland GmbH & Co.KG DE-AR-000006164
Sources (1)
- EUDAMED 17979ef3-6f92-42b1-9a1b-69a5db050f27 61 fields · synced Jun 18, 2026