Identity
- Trade Name
- Adhesive electrodes EUDAMED
- Device Name
- Adhesive electrodes for Neurodiagnostic, Cardiology and Electrostimulation EUDAMED
- Model / Reference
- DENIS25026 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18054655007753 EUDAMED
- Basic UDI-DI
- 8054655000014XZ EUDAMED
- EMDN Code
- N010199 NEUROPHYSIOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Adhesive electrodes by Spes Medica S.p.A. — Class I — 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 | 8054655000014XZ | Class I | Active |
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Manufacturer
- Manufacturer
- Spes Medica S.p.A.
- EUDAMED SRN
- IT-MF-000008858
Sources (1)
- EUDAMED 94a5a79b-cb12-4d84-8a45-237f12642ee1 61 fields · synced May 22, 2026