Identity
- Trade Name
- swaromed EUDAMED
- Device Name
- ECG Electrode EUDAMED
- Model / Reference
- swaromed EUDAMED1057 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060441917850 EUDAMED
- Basic UDI-DI
- 506044191ECG-Elec1QZ 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
swaromed by Nissha Medical Technologies Ltd — 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 | 506044191ECG-Elec1QZ | 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 d1b75fe9-7ee0-40b9-a90a-7bdd92f296dc 61 fields · synced Jun 17, 2026