Identity
- Trade Name
- Monopolar needle electrode EUDAMED
- Device Name
- Electromyography (EMG) needle electrodes EUDAMED
- Model / Reference
- TFDN351332 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18054655026389 EUDAMED
- Basic UDI-DI
- 8054655000001XQ EUDAMED
- EMDN Code
- N010101 ELECTROMYOGRAPHIC ELECTRODES 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
Monopolar 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 | 8054655000001XQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Spes Medica S.p.A.
- EUDAMED SRN
- IT-MF-000008858
Sources (1)
- EUDAMED af600209-c686-4410-8c0c-23f106dbda45 61 fields · synced Jun 18, 2026