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Nebulization Module
EUDAMEDClass IIa (EU MDR)
Ref 06934325308494Model MDpro5PRef MDpro8P
Identity
- Device Name
- Nebulization Module EUDAMED
- Model / Reference
- MDpro5P EUDAMED06934325308494 EUDAMEDMDpro8P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934325308494 EUDAMED06934325308500 EUDAMED
- Basic UDI-DI
- 69343253R068020BM8X EUDAMED
- EMDN Code
- R0680 NEBULISATION AND HUMIDIFICATION SYSTEMS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
Nebulization Module by Feellife Health Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69343253R068020BM8X | 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 (2)
- EUDAMED c86391f5-0f0b-44f4-b402-d405ba27487e 61 fields · synced Jul 27, 2026
- EUDAMED b2e151f9-04a1-4786-9db0-9a50a8b74486 61 fields · synced May 19, 2026