Je-225AK
Je-225AK is a Class II device made by Nihon Kohden America, Inc., listed in FDA GUDID since 19 Sep 2016 (UDI-DI 00841983102455), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00841983102455 | Date19 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 00841983102455
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Generic name
- Electroencephalograph
- Model / Ref / Catalog
- JE-225AK
- Primary DI / UDI-DI
- 00841983102455
- FDA product code
- OLT, GYC, GWQ
- GMDN term
- Electroencephalograph
- Device class
- Class II
- Regulation number
- 882.1400, 882.1310
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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