Identity
- Trade Name
- EPTE BIPOLAR System EUDAMED
- Device Name
- EPTE BIPOLAR EUDAMED
- Model / Reference
- EPTEV02 EUDAMEDEPTEV02DEV01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08437023158012 EUDAMED
- Basic UDI-DI
- 8437023158EPTEV02LQ EUDAMED
- EMDN Code
- Z12062899 NEUROMUSCULAR STIMULATION EQUIPMENT - OTHER 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
EPTE BIPOLAR System by Ionclinics & Deionic, S.l. — 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 | 8437023158EPTEV02LQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ionclinics & Deionic, S.l.
- EUDAMED SRN
- ES-MF-000020207
Sources (1)
- EUDAMED 08caaccc-f4ad-46bd-a52d-8e5bd0e95781 61 fields · synced Jul 11, 2026