Identity
- Trade Name
- NICO BrainPath Approach EUDAMED
- Device Name
- NICO BrainPath Approach EUDAMED
- Model / Reference
- NN-2503 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816744022532 EUDAMED
- Basic UDI-DI
- 081674402PP1FG EUDAMED
- EMDN Code
- Z12109099 VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Medical Purpose
- To provide for access and allow for visualization of the surgical field during brain and spinal surgery. Indications may include subcortical access to diseases such as Primary/Secondary brain tumors, Vascular abnormalities/malformations, Intraventricular tumors/cysts EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
NICO BrainPath Approach by NICO Corporation — Class III — 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 | 081674402PP1FG | Class III | Active |
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Manufacturer
- Manufacturer
- NICO Corporation
- EUDAMED SRN
- US-PR-000035011
Sources (1)
- EUDAMED fe097696-1d7d-48c8-800b-75b85cb92d13 61 fields · synced May 22, 2026