Identity
- Trade Name
- feellife EUDAMEDPortable Mesh Nebulizer FDA UDI
- Generic Name
- Therapeutic agent nebulizer, benchtop FDA UDI
- Device Name
- Portable Mesh Nebulizer EUDAMED
- Model / Reference
- Air Mask D EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06934325302249 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06934325302249 EUDAMED
- 510(k) Number
- K182906 FDA UDI
- FDA Product Code
- CAF FDA UDI
- EMDN Code
- R060101 COLD NEBULISATION SYSTEMS EUDAMED
- GMDN Term
- Therapeutic agent nebulizer, benchtop FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5630 FDA UDI
- Market of Registration
- France 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
feellife by Feellife Health Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06934325302249 | 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 481c6e00-9f6a-43e6-abd9-a7e52b14e989 61 fields · synced Jul 9, 2026
- FDA UDI 6aaaf8a9-dd3c-4d51-b6b5-ba29cadf1a0d 33 fields · synced May 30, 2026