Identity
- Trade Name
- VersaTrode EUDAMED
- Device Name
- ECG Electrode EUDAMED
- Model / Reference
- VersaTrode EUDAMEDFW32P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060441918369 EUDAMED
- Basic UDI-DI
- 506044191ECG-Elec2R3 EUDAMED
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
VersaTrode by Nissha Medical Technologies Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 506044191ECG-Elec2R3 | Class I | Active |
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Manufacturer
- Manufacturer
- Nissha Medical Technologies Ltd
- EUDAMED SRN
- GB-MF-000012057
- Authorised Representative
- NISSHA MEDICAL TECHNOLOGIES SAS FR-AR-000009795
Sources (1)
- EUDAMED 734b9464-2483-4278-a674-d23d507ddccb 61 fields · synced Jun 17, 2026