Identity
- Trade Name
- AllNEB EUDAMED
- Device Name
- Breath-actuated nebulizer EUDAMED
- Model / Reference
- EN-BAN-200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719882300110 EUDAMED
- Basic UDI-DI
- 471988230ENBAN0102113Z EUDAMED
- EMDN Code
- R0699 NEBULISATION AND HUMIDIFICATION SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
AllNEB by Enchant Tek Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242354 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 471988230ENBAN0102113Z | Class IIa | Active |
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Manufacturer
- Manufacturer
- Enchant Tek Co., Ltd.
- EUDAMED SRN
- TW-MF-000037003
- Authorised Representative
- Wellell Iberia S.L. ES-AR-000003668
Sources (2)
- EUDAMED 1c3a278a-5cb1-435b-bf8a-4334fcd1f4dd 61 fields · synced Jun 19, 2026
- FDA 510(k) K242354 1 fields · synced May 18, 2026