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Portable Mesh Nebulizer
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref NE-U300-EModel NE-U300510(k) K182906
Identity
- Device Name
- Portable Mesh Nebulizer EUDAMED
- Model / Reference
- NE-U300 EUDAMEDNE-U300-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934325307862 EUDAMED
- Basic UDI-DI
- 69343253R06010117C8L EUDAMED
- Direct Marketing DI
- 06934325307862 EUDAMED
- EMDN Code
- R060101 COLD NEBULISATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Portugal 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
Portable Mesh Nebulizer by Feellife Health Inc. — 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 | K182906 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69343253R06010117C8L | Class IIa | Active |
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Manufacturer
- Manufacturer
- Feellife Health Inc.
- EUDAMED SRN
- CN-MF-000000782
- FDA Applicant
- Feellife Health, Inc.
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 369f298b-2481-459c-a70a-5d7ff28f9e7c 85 fields · synced Jun 18, 2026
- FDA 510(k) K182906 1 fields · synced May 18, 2026