Identity
- Device Name
- Nebulizer Mask EUDAMED
- Model / Reference
- XL7 EUDAMEDL7 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934325307015 EUDAMED06934325307022 EUDAMED
- Basic UDI-DI
- 69343253R030132BYJ EUDAMED
- Direct Marketing DI
- 06934325307015 EUDAMED06934325307022 EUDAMED
- EMDN Code
- R03010301 AEROSOL THERAPY MASKS 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
Nebulizer Mask 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 | 69343253R030132BYJ | 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 cd676396-326e-4254-9b21-44bc13955287 61 fields · synced Jul 31, 2026
- EUDAMED 923dd62b-6d12-4323-8f27-57453d7707dc 61 fields · synced May 19, 2026