Identity
- Trade Name
- PIC solution EUDAMED
- Device Name
- ECG Electrode EUDAMED
- Model / Reference
- ES GS 3648 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05905858930224 EUDAMED
- Basic UDI-DI
- 5903246098ECGELECTRODEXB EUDAMED
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
PIC solution by Esvico 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 | 5903246098ECGELECTRODEXB | Class I | Active |
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Manufacturer
- Manufacturer
- Esvico Sp. z o.o.
- EUDAMED SRN
- PL-MF-000022702
Sources (1)
- EUDAMED d263f6c5-4ac5-4b9f-869e-cfe4410389d2 61 fields · synced Jun 19, 2026