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Lead-Lok
EUDAMEDClass I (EU MDR)
Ref R‐LFO‐550Model Lead-LokRef R‐LFO‐500Ref BLLM50Ref R‐LFO‐360Ref N‐LFO‐550Ref BPL‐LFO‐32Ref R‐LLL‐510Ref N-LFO-500
Identity
- Trade Name
- Lead-Lok EUDAMED
- Device Name
- ECG Electrode EUDAMED
- Model / Reference
- Lead-Lok EUDAMEDR‐LFO‐550 EUDAMEDR‐LFO‐500 EUDAMEDBLLM50 EUDAMEDR‐LFO‐360 EUDAMEDN‐LFO‐550 EUDAMEDBPL‐LFO‐32 EUDAMEDR‐LLL‐510 EUDAMEDN-LFO-500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060441919083 EUDAMED05060441919069 EUDAMED05060441918963 EUDAMED05060441919052 EUDAMED05060441919038 EUDAMED05060441919007 EUDAMED05060441919090 EUDAMED05060441919021 EUDAMED
- Basic UDI-DI
- 506044191ECG-Elec3R5 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
Lead-Lok 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-Elec3R5 | 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 (8)
- EUDAMED 82749cad-19e6-4e8b-af6d-ebe9a316ee9b 61 fields · synced Oct 6, 2026
- EUDAMED d8e79a0d-b141-4593-bf92-e8bc71906269 61 fields · synced May 17, 2026
- EUDAMED 39724f00-71e3-416a-971b-64dec46dd1e5 61 fields · synced May 17, 2026
- EUDAMED 913df80b-7ffc-412b-ae31-adb55f905789 61 fields · synced May 17, 2026
- EUDAMED fbab9836-5042-4458-9cec-f5094370db93 61 fields · synced May 17, 2026
- EUDAMED 6d14956f-df58-4f5e-853d-a6e35ef80ccb 61 fields · synced May 18, 2026
- EUDAMED e1a5e433-a38e-4c40-9bef-4dfaba9c5c5c 61 fields · synced May 18, 2026
- EUDAMED 39545f77-15ac-4170-a5f4-d484b88a393c 61 fields · synced May 18, 2026