Identity
- Trade Name
- EPTE BIPOLAR tDCS EUDAMED
- Device Name
- EPTE BIPOLAR EUDAMED
- Model / Reference
- EPTEV02 EUDAMEDEPTEV02DEV02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08437023158029 EUDAMED
- Basic UDI-DI
- 8437023158EPTEV02LQ EUDAMED
- EMDN Code
- Z12101106 NEUROLOGICAL STIMULATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Category: Point aesthesiometer
EPTE BIPOLAR tDCS by Ionclinics & Deionic, S.l. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 8437023158EPTEV02LQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ionclinics & Deionic, S.l.
- EUDAMED SRN
- ES-MF-000020207
Sources (1)
- EUDAMED 5ed891b8-4881-4454-ab19-35302c47077d 61 fields · synced Jul 19, 2026