Identity
- Trade Name
- STIMULATION POD JS-101B EUDAMEDNA FDA UDI
- Generic Name
- Neurophysiologic monitoring system FDA UDI
- Device Name
- Evoked-potential graphic recording system EUDAMEDStimulation Pod, High, MEE-1000 FDA UDI
- Model / Reference
- JS-101B EUDAMEDFDA UDI
- Description
- Stimulation Pod, High, MEE-1000 FDA UDI
Identifiers
- Catalog Number
- JS-101B FDA UDI
- Primary DI / UDI-DI
- 04931921103166 EUDAMEDFDA UDI
- Basic UDI-DI
- 4931921MD10013BE EUDAMED
- FDA Product Code
- GWF FDA UDIGYC FDA UDI
- EMDN Code
- Z12101180 PERIPHERAL OR CENTRAL NEURO STIMULATION AND ASSESSMENT INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Neurophysiologic monitoring system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1870 FDA UDI882.1310 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Stimulation Pod Js-101b by Nihon Kohden Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4931921MD10013BE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Nihon Kohden Corporation
- EUDAMED SRN
- JP-MF-000019022
- Authorised Representative
- NIHON KOHDEN EUROPE GmbH DE-AR-000010740
Sources (2)
- EUDAMED bd5c112d-8f82-4a60-adf6-cf45f816f10e 61 fields · synced Jul 10, 2026
- FDA UDI 9606bdc0-e176-4266-a051-b3255240ea79 35 fields · synced May 29, 2026