AllNEB
Ref EN-BAN-200
AllNEB (EN-BAN-200) is a medical device (EU MDR Class IIa; EMDN category nebulisation and humidification systems) made by Enchant Tek. Co, Ltd., registered in EUDAMED on 15 May 2025 (Basic UDI-DI 471988230ENBAN0102113Z) and cleared under FDA 510(k) K242354 on 29 Apr 2025, active as of 23 Oct 2026.
Active
CE MDR 510(k)
Valid until
No date given
FDA recalls
None found
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number471988230ENBAN0102113Z 04719882300110 | Date15 May 2025 | StatusActive |
| United States | FDA 510(k) 510(k) | NumberK242354 | Date29 Apr 2025 | StatusActive |
Official records
- EUDAMED public site 471988230ENBAN0102113Z
- FDA 510(k) database K242354
Across registries
- EUDAMED Basic UDI-DI 471988230ENBAN0102113Z registered 15 May 2025 Active
- FDA 510(k) K242354 decided 29 Apr 2025 Active
Timeline
- Cleared FDA 510(k) K242354
- Registered EUDAMED 471988230ENBAN0102113Z
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- United States
- European Union
Specification
- Device name
- Breath-actuated nebulizer
- Model / reference
- EN-BAN-200
- Primary DI / UDI-DI
- 04719882300110
- Basic UDI-DI
- 471988230ENBAN0102113Z
- EMDN code
- R0699 Nebulisation and humidification systems - other
- Device class
- Class IIa
- EU registration type
- Standard device
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- TW-MF-000037003
- Authorised representative
- Wellell Iberia S.L. ES-AR-000003668
Similar devices in this category
Other devices filed under NEBULISATION AND HUMIDIFICATION SYSTEMS - OTHER.