Identity
- Trade Name
- ESVIsensor EUDAMED
- Device Name
- ECG Electrode EUDAMED
- Model / Reference
- ES GS 3648 T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903246098617 EUDAMED
- Basic UDI-DI
- 5903246098ECGELECTRODEXB 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
ESVIsensor 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Esvico Sp. z o.o.
- EUDAMED SRN
- PL-MF-000022702
Sources (1)
- EUDAMED 8c573644-c5c0-47ce-ac46-ada3304a1399 61 fields · synced Jun 19, 2026