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Miniaturized Pneumotachograph
EUDAMEDClass IIa (EU MDR)
Ref SEN514Model Pneumotachograph
Identity
- Trade Name
- Miniaturized Pneumotachograph EUDAMED
- Model / Reference
- Pneumotachograph EUDAMEDSEN514 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413402229 EUDAMED
- Basic UDI-DI
- 42504134mPTGQG EUDAMED
- EMDN Code
- Z12159008 PNEUMOTACHOGRAPHS 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Miniaturized Pneumotachograph by SOMNOmedics AG — 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 | 42504134mPTGQG | Class IIa | Active |
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Manufacturer
- Manufacturer
- SOMNOmedics AG
- EUDAMED SRN
- DE-MF-000006921
Sources (1)
- EUDAMED fb633fa9-770e-4007-b698-39f6ca9d7913 61 fields · synced Jul 9, 2026