Identity
- Trade Name
- DENA EUDAMED
- Device Name
- Disposable ECG Electrode EUDAMED
- Model / Reference
- DEE-AS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06262298000030 EUDAMED
- Basic UDI-DI
- 062622980DEE-ASWE EUDAMED
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
Classification
- Device Class
- Class I 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: Electrocardiographic electrode, single-use
Dena by Dadeh Gostaran Dena — Class I — 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 | 062622980DEE-ASWE | Class I | Active |
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Manufacturer
- Manufacturer
- Dadeh Gostaran Dena
- EUDAMED SRN
- IR-MF-000038532
- Authorised Representative
- Eska Diagnostics Kft HU-AR-000037211
Sources (1)
- EUDAMED 25078dd0-1947-4ad2-b796-b376de0feaeb 61 fields · synced Jul 11, 2026