Na Js-102B
Ref JS-102B
Active
CE MDR
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number4931921MD10014BG 04931921103173 | Date17 May 2026 | StatusActive |
| United States | GUDID listing GUDID | Number04931921103173 | Date5 Sep 2016 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Simulation Pod JS-102B
- Generic name
- Neurophysiologic monitoring system
- Device name
- Electroencephalograph
- Model / Ref / Catalog
- JS-102B
- Primary DI / UDI-DI
- 04931921103173
- Basic UDI-DI
- 4931921MD10014BG
- FDA product code
- GYC
- EMDN code
- Z12100380 Electroencephalography instruments - hardware accessories
- GMDN term
- Neurophysiologic monitoring system
- Device class
- Class I EUDAMEDClass II GUDID
- Regulation number
- 882.1310
- EU registration type
- Standard device
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class I | Class II |
Other devices from Nihon Kohden Corp.
Properties
Other properties (23)
- Supplied sterile: No
- Sterilise before use: No
- Single use: No
- Implantable: No
- Reusable: No
- Contains latex: No
- Reprocessed single-use device: No
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
- Incorporates a substance derived from human blood or plasma: No
- Contains human tissues or cells: No
- Contains animal tissues or cells: No
- Contains endocrine-disrupting substances: No
- Administering medicine: No
- Measuring function: No
- Incorporates a medicinal substance: No
- Over-the-counter: No
- Convenience kit: No
- Combination product: No
- HCT/P: No
- Premarket exempt: No
- Lot / batch number: No
- Expiration date: No
- Manufacturing date: No