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Lumed
EUDAMEDClass I (EU MDR)
Ref ET1119/NIModel LumedRef ET1166/NIRef ET4136/NI
Identity
- Trade Name
- Lumed EUDAMED
- Device Name
- ECG Electrode EUDAMED
- Model / Reference
- Lumed EUDAMEDET1119/NI EUDAMEDET1166/NI EUDAMEDET4136/NI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15060842920241 EUDAMED15060842920258 EUDAMED15060842920265 EUDAMED
- Basic UDI-DI
- 50604419ECG-Elec8UQ EUDAMED
- Unit of Use DI
- 05060842920244 EUDAMED05060842920251 EUDAMED05060842920268 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
Category: Electrocardiographic electrode, single-use
Lumed 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 | 50604419ECG-Elec8UQ | 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 (3)
- EUDAMED 27d29872-8464-45c6-9682-912a177f7fd1 61 fields · synced Jul 20, 2026
- EUDAMED a9864f1e-5aae-46ac-9156-53bc6ba36a9d 61 fields · synced May 19, 2026
- EUDAMED 2faea11f-9aad-45f7-9b22-1c4c94d3cea4 61 fields · synced May 19, 2026