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NovaStar plus NIVMaske, AAV, M
EUDAMEDClass IIa (EU MDR)
Ref MP05062Model 2080026K19X110
Identity
- Trade Name
- NovaStar plus NIVMaske, AAV, M EUDAMED
- Model / Reference
- 2080026K19X110 EUDAMEDMP05062 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675624165 EUDAMED
- Basic UDI-DI
- 0404867512080026K19X110P2 EUDAMED
- EMDN Code
- R0301010202 NIV MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Category: Rebreathing oxygen face mask
NovaStar plus NIVMaske, AAV, M by Drägerwerk AG & Co. KGaA — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Rebreathing oxygen face mask.
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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 | 0404867512080026K19X110P2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Drägerwerk AG & Co. KGaA
- EUDAMED SRN
- DE-MF-000005329
Sources (1)
- EUDAMED 3cd7872e-4a98-4659-872b-e075e13a355a 61 fields · synced Aug 4, 2026