Identity
- Trade Name
- EEG Disk Electrode NE-116A EUDAMED
- Device Name
- Electroencephalograph EUDAMED
- Model / Reference
- H503C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04931921889077 EUDAMED
- Basic UDI-DI
- 4931921MD10014BG EUDAMED
- EMDN Code
- N01010299 EEG ELECTRODES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
EEG Disk Electrode NE-116A by Nihon Kohden Corporation — 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 | 4931921MD10014BG | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nihon Kohden Corporation
- EUDAMED SRN
- JP-MF-000019022
- Authorised Representative
- NIHON KOHDEN EUROPE GmbH DE-AR-000010740
Sources (1)
- EUDAMED a21e4881-50c6-49b5-8d4f-76465299a81d 61 fields · synced Jun 18, 2026