Identity
- Trade Name
- Elektrody EKG EUDAMED
- Device Name
- Disposable ECG electrodes EUDAMED
- Model / Reference
- EK-S EUDAMEDEK-S 62 PSG XC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903002215753 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
Category: Electrocardiographic electrode, single-use
Elektrody EKG by SORIMEX sp. z o.o. — Class I — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Electrocardiographic electrode, single-use.
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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 | 5903002221125B | Class I | Active |
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Manufacturer
- Manufacturer
- SORIMEX sp. z o.o.
- EUDAMED SRN
- PL-MF-000020958
Sources (1)
- EUDAMED 655bfa6a-ea79-4949-b3e6-ec1223c3b47b 61 fields · synced Oct 7, 2026