← Back to catalogue
Flow pressure sensor for SOMNOtouch NIBP
EUDAMEDClass IIa (EU MDR)
Ref TOS100Model Flow sensorRef TON100Model SOMNOtouch NIBP
Identity
- Trade Name
- Flow pressure sensor for SOMNOtouch NIBP EUDAMEDSOMNOtouch NIBP EUDAMED
- Model / Reference
- Flow sensor EUDAMEDTOS100 EUDAMEDSOMNOtouch NIBP EUDAMEDTON100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413405060 EUDAMED04250413405008 EUDAMED
- Basic UDI-DI
- 42504134FlowPS2 EUDAMED42504134SOMNOtouchNIBPXX EUDAMED
- EMDN Code
- Z12159008 PNEUMOTACHOGRAPHS EUDAMEDZ12100501 POLYSOMNOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
- Medical Purpose
- The SOMNOtouch™ NIBP is a portable device for recording physiological signals. The SOMNOtouch™ NIBP is used as a long-term blood pressure and long-term ECG device. 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
Flow pressure sensor for SOMNOtouch NIBP 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 | 42504134FlowPS2 | 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 (2)
- EUDAMED 27d0eb32-58cb-4036-94ef-9a67628772d6 61 fields · synced Jul 19, 2026
- EUDAMED 35541258-4249-4ed2-89c6-c2d197e7af7e 61 fields · synced Jul 19, 2026