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NARCOguide, Basic-Version
EUDAMEDClass IIb (EU MDR)
Ref DOA100-RTB-1Model NARCOguide
Identity
- Trade Name
- NARCOguide, Basic-Version EUDAMED
- Model / Reference
- NARCOguide EUDAMEDDOA100-RTB-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413410941 EUDAMED
- Basic UDI-DI
- 42504134NARCOguideD6 EUDAMED
- EMDN Code
- Z12100302 ELECTROENCEPHALOGRAPHS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Medical Purpose
- The NARCOguide® is a portable device that assists the physician in assessing the depth of anaesthesia by recording physiological signals. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
NARCOguide, Basic-Version by SOMNOmedics AG — Class IIb — 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 | 42504134NARCOguideD6 | Class IIb | Active |
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Manufacturer
- Manufacturer
- SOMNOmedics AG
- EUDAMED SRN
- DE-PR-000042026
Sources (1)
- EUDAMED 6cabe6cd-1f70-4f57-a56d-2e559a4af632 61 fields · synced Jul 29, 2026