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Aldo-union
EUDAMEDClass IIa (EU MDR)
Ref Nebualdo Hands-Free (Air Mask II)Model Air Mask II
Identity
- Trade Name
- Aldo-union EUDAMED
- Device Name
- Portable Mesh Nebulizer EUDAMED
- Model / Reference
- Air Mask II EUDAMEDNebualdo Hands-Free (Air Mask II) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934325311210 EUDAMED
- Basic UDI-DI
- 69343253R06010120B82 EUDAMED
- Direct Marketing DI
- 06934325311210 EUDAMED
- EMDN Code
- R060101 COLD NEBULISATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Aldo-union 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 | 69343253R06010120B82 | 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 (1)
- EUDAMED 2feda9d1-9297-4469-a946-2aa8c364175e 61 fields · synced Jul 15, 2026