Identity
- Trade Name
- NARCOguide, Basic-Version EUDAMED
- Model / Reference
- NARCOguide EUDAMEDDOA100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413410927 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SOMNOmedics AG
- EUDAMED SRN
- DE-PR-000042026
Sources (1)
- EUDAMED 1300189c-222e-466f-add7-691f38987d57 61 fields · synced Jul 12, 2026