Identity
- Trade Name
- Breakout Box JB-101B EUDAMED
- Device Name
- Evoked-potential graphic recording system EUDAMED
- Model / Reference
- JB-101BKMK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04931921131626 EUDAMED
- Basic UDI-DI
- 4931921MD10013BE EUDAMED
- EMDN Code
- Z12101180 PERIPHERAL OR CENTRAL NEURO STIMULATION AND ASSESSMENT INSTRUMENTS - HARDWARE ACCESSORIES 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
Breakout Box JB-101B 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 | 4931921MD10013BE | Class I | Active |
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Manufacturer
- Manufacturer
- Nihon Kohden Corporation
- EUDAMED SRN
- JP-MF-000019022
- Authorised Representative
- NIHON KOHDEN EUROPE GmbH DE-AR-000010740
Sources (1)
- EUDAMED 6ae6807f-da5c-462c-b728-f003706daa89 61 fields · synced Jun 18, 2026