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NovaStar plus, NIVmaske, SE, M
EUDAMEDClass IIa (EU MDR)
Ref MP05052Model 2080026K19X100
Identity
- Trade Name
- NovaStar plus, NIVmaske, SE, M EUDAMED
- Model / Reference
- 2080026K19X100 EUDAMEDMP05052 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675624080 EUDAMED
- Basic UDI-DI
- 0404867512080026K19X100NX 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, SE, 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 | 0404867512080026K19X100NX | Class IIa | Active |
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Manufacturer
- Manufacturer
- Drägerwerk AG & Co. KGaA
- EUDAMED SRN
- DE-MF-000005329
Sources (1)
- EUDAMED 0ee33d61-e3fe-4ed2-8381-f411ea14d960 61 fields · synced Jun 18, 2026