Identity
- Trade Name
- Subdermal needle electrode EUDAMED
- Device Name
- Electroencephalography (EEG) needle electrodes EUDAMED
- Model / Reference
- MN3515D15I/L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18054655029359 EUDAMED
- Basic UDI-DI
- 8054655000010XR EUDAMED
- EMDN Code
- N01010299 EEG ELECTRODES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Subdermal needle electrode by Spes Medica S.p.A. — 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 | 8054655000010XR | Class IIa | Active |
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Manufacturer
- Manufacturer
- Spes Medica S.p.A.
- EUDAMED SRN
- IT-MF-000008858
Sources (1)
- EUDAMED 66d9bb75-e98e-4f20-a7f8-4e35f91a1a65 61 fields · synced May 22, 2026