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Intercostal EMG sensor
EUDAMEDClass IIa (EU MDR)
Ref SEN623Model Activity sensorRef NGS058
Identity
- Trade Name
- Intercostal EMG sensor EUDAMEDIntercostal-EMG Sensor EUDAMED
- Model / Reference
- Activity sensor EUDAMEDSEN623 EUDAMEDNGS058 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413401420 EUDAMED04250413410811 EUDAMED
- Basic UDI-DI
- 42504134MovementEP 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
Intercostal EMG sensor 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 | 42504134MovementEP | Class IIa | Active |
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Manufacturer
- Manufacturer
- SOMNOmedics AG
- EUDAMED SRN
- DE-MF-000006921
Sources (2)
- EUDAMED 2fe689e0-5cb2-4313-8280-ba47c3b9d1ca 61 fields · synced Jul 18, 2026
- EUDAMED 38dd7b5a-ac42-466f-88ae-ae50ef7dcab9 61 fields · synced May 18, 2026