← Back to catalogue
Soft Silicone Finger Sensor for Pulse Oximeter
EUDAMEDClass IIa (EU MDR)
Ref SEN209Model SpO2 sensorRef SEN215Ref SEN224
Identity
- Trade Name
- Soft Silicone Finger Sensor for Pulse Oximeter EUDAMED
- Model / Reference
- SpO2 sensor EUDAMEDSEN209 EUDAMEDSEN215 EUDAMEDSEN224 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413406500 EUDAMED04250413406517 EUDAMED04250413406524 EUDAMED
- Basic UDI-DI
- 42504134FC4Z EUDAMED
- EMDN Code
- Z1203020280 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
Soft Silicone Finger Sensor for Pulse Oximeter 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 | 42504134FC4Z | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SOMNOmedics AG
- EUDAMED SRN
- DE-MF-000006921
Sources (3)
- EUDAMED 04351431-7ff4-4349-9dc3-d523b62811da 61 fields · synced Sep 18, 2026
- EUDAMED f644e28f-9908-4399-9455-93626f667503 61 fields · synced May 17, 2026
- EUDAMED 7d8109d4-1ded-4d95-8baf-5a1d07936d3b 61 fields · synced May 19, 2026