Identity
- Trade Name
- NEMCA162 EUDAMED
- Device Name
- DR400 patient cable EUDAMED
- Model / Reference
- NEMCA162 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M582NEMCA1620 EUDAMED
- Basic UDI-DI
- ++M582NEMCASSAH EUDAMED
- EMDN Code
- Z12030680 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
Nemca162 by NorthEast Monitoring, Inc. — 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 | ++M582NEMCASSAH | 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 10dbef8b-34a7-4874-a1cc-0cdfbb79b6d2 61 fields · synced Jun 19, 2026