Identity
- Trade Name
- EPTE SYSTEM EUDAMED
- Device Name
- EPTE SYSTEM EUDAMED
- Model / Reference
- EPTEV01V01 EUDAMEDEPTEV01DEV01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08437023158036 EUDAMED
- Basic UDI-DI
- 8437023158EPTEV01LN EUDAMED
- EMDN Code
- Z120601,Z120623 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 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 | 8437023158EPTEV01LN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ionclinics & Deionic, S.l.
- EUDAMED SRN
- ES-MF-000020207
Sources (1)
- EUDAMED 39ed8caf-4880-4f36-b3a7-992faa0f2e0b 61 fields · synced Jun 19, 2026