NExT-AS B9109000141
by Eb Neuro SpA
NExT-AS B9109000141 is a Class II device made by Eb Neuro SpA, cleared under FDA 510(k) K242832 on 12 Dec 2024 and listed in FDA GUDID since 22 May 2025 (UDI-DI 08056446901199), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08056446901199 | Date22 May 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK242832 | Date12 Dec 2024 | StatusActive |
Official records
- AccessGUDID record 08056446901199
- FDA 510(k) database K242832
Across registries
- FDA 510(k) K242832 decided 12 Dec 2024 Active
- FDA GUDID UDI-DI 08056446901199 listed 22 May 2025 Listed
Timeline
- Cleared FDA 510(k) K242832
- Listed FDA GUDID 08056446901199
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- NExT-AS
- Generic name
- Electromyograph
- Model / reference
- B9109000141
- Primary DI / UDI-DI
- 08056446901199
- 510(k) Number
- FDA product code
- GWL, OLT, IKN, GWE, GWF, GWJ
- GMDN term
- Electromyograph
- Device class
- Class II
- Regulation number
- 882.1835, 882.1400, 890.1375, 882.1890, 882.1870, 882.1900
- GUDID distribution status
- In Commercial Distribution
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