Identity
- Trade Name
- NEMEL002 EUDAMED
- Device Name
- NEMEL electrode patch used with the DR400 EUDAMED
- Model / Reference
- NEMEL002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M582NEMEL0020 EUDAMED
- Basic UDI-DI
- ++M582NEMELCD 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
Nemel002 by North East Monitoring, Inc. — 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 | ++M582NEMELCD | Class I | Active |
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Manufacturer
- Manufacturer
- NorthEast Monitoring, Inc.
- EUDAMED SRN
- US-MF-000019819
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (1)
- EUDAMED 9509b96b-728c-443a-a5d0-20744cfd7f87 61 fields · synced Jul 23, 2026