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Medical Mesh Nebulizer
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref AirPro Plus+Model AirICU Plus+Ref AirICU Мах+ Model AirICU Мах+Ref AirPro Max+
Identity
- Device Name
- Medical Mesh Nebulizer EUDAMED
- Model / Reference
- AirICU Plus+ EUDAMEDAirPro Plus+ EUDAMEDAirICU Мах+ EUDAMEDAirPro Max+ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934325310404 EUDAMED06934325306773 EUDAMED06934325310398 EUDAMED
- Basic UDI-DI
- 69343253R06010125D8M EUDAMED69343253R06010125F8R EUDAMED
- Direct Marketing DI
- 06934325310404 EUDAMED06934325306773 EUDAMED06934325310398 EUDAMED
- EMDN Code
- R060101 COLD NEBULISATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMEDBelgium 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
Medical 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 | K251584 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69343253R06010125D8M | Class IIa | Active |
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Manufacturer
- Manufacturer
- Feellife Health Inc.
- EUDAMED SRN
- CN-MF-000000782
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (4)
- EUDAMED b2612b83-f1a0-466c-89e3-49a0b05ac0e2 61 fields · synced Jul 18, 2026
- EUDAMED 960d5b47-7e2d-4e06-938b-fdd5232fab42 61 fields · synced May 17, 2026
- EUDAMED b28c6a5f-124f-44be-bff7-d1384d245dd4 61 fields · synced May 17, 2026
- FDA 510(k) K251584 1 fields · synced May 18, 2026