Identity
- Trade Name
- ECG Electrodes EUDAMED
- Device Name
- Disposable ECG electrodes EUDAMED
- Model / Reference
- EK-S EUDAMEDEK-S 50 PSG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903002202333 EUDAMED
- Basic UDI-DI
- 5903002221125B EUDAMED
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
ECG Electrodes by SORIMEX sp. z o.o. — Class I — 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 | 5903002221125B | Class I | Active |
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Manufacturer
- Manufacturer
- SORIMEX sp. z o.o.
- EUDAMED SRN
- PL-MF-000020958
Sources (1)
- EUDAMED 4038eb30-784c-4e29-81d2-4747ac94c494 61 fields · synced Jun 18, 2026