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Portable Mesh Nebulizer
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref Air ProModel Aerogo-G
Identity
- Trade Name
- Portable Mesh Nebulizer FDA UDI
- Generic Name
- Nebulizing system delivery set, reusable FDA UDI
- Device Name
- Portable Mesh Nebulizer EUDAMED
- Model / Reference
- Aerogo-G EUDAMEDAir Pro EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06934325358475 EUDAMEDFDA UDI
- Basic UDI-DI
- 69343253R06010115P98 EUDAMED
- Direct Marketing DI
- 06934325358475 EUDAMED
- 510(k) Number
- K182906 FDA UDI
- FDA Product Code
- CAF FDA UDI
- EMDN Code
- R060101 COLD NEBULISATION SYSTEMS EUDAMED
- GMDN Term
- Nebulizing system delivery set, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5630 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Portable Mesh Nebulizer by Feellife Health Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69343253R06010115P98 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Feellife Health Inc.
- EUDAMED SRN
- CN-MF-000000782
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 6a65d1fa-c6d9-4052-b190-9d87ff8a7c8b 61 fields · synced Jul 10, 2026
- FDA UDI 756fa451-43ac-4380-8a42-933bea9077b1 33 fields · synced May 30, 2026