Identity
- Trade Name
- ECG Electrodes EUDAMED
- Device Name
- Disposable ECG electrodes EUDAMED
- Model / Reference
- EK-S EUDAMEDEK-S 45 PSG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05908212623060 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
ECG Electrodes by SORIMEX sp. z o.o. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic electrode, single-use.
- ECG leadwire — Shenzhen City Teveik Technology Co., Ltd. · Class I
- ECG — Zoll Medical Corporation · Class II
- SWAROMED — TYROLMED GmbH · Class II
- SWAROMED — TYROLMED GmbH · Class II
- SWAROMED — TYROLMED GmbH · Class II
- PG10S /RU26 — FIAB S.p.A. · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Kendall — Cardinalhealth · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SORIMEX sp. z o.o.
- EUDAMED SRN
- PL-MF-000020958
Sources (1)
- EUDAMED c788b318-5387-4a28-a773-1b341c4003ec 61 fields · synced Jun 18, 2026