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CPAP Pressure Sensor (0-24 mbar)
EUDAMEDClass IIa (EU MDR)
Ref SEN639Model CPAP sensorRef SEW121
Identity
- Trade Name
- CPAP Pressure Sensor (0-24 mbar) EUDAMEDCPAP-Sensor EUDAMED
- Model / Reference
- CPAP sensor EUDAMEDSEN639 EUDAMEDSEW121 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413406319 EUDAMED04250413405596 EUDAMED
- Basic UDI-DI
- 42504134CPAP-senN2 EUDAMED
- EMDN Code
- Z12159008 PNEUMOTACHOGRAPHS EUDAMEDZ1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES 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
CPAP Pressure Sensor (0-24 mbar) 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 | 42504134CPAP-senN2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- SOMNOmedics AG
- EUDAMED SRN
- DE-MF-000006921
Sources (2)
- EUDAMED 7477eefd-7320-43a2-98d2-222dcad669e7 61 fields · synced Aug 3, 2026
- EUDAMED 4ba1dd0a-228e-4a64-b8a6-e84328aca173 61 fields · synced May 19, 2026