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Mesh Nebulizer
EUDAMEDClass IIa (EU MDR)
Ref AE-02Model AE-01、 AE-02 、AE-03Ref AE-01Ref AE-03
Identity
- Trade Name
- Mesh Nebulizer EUDAMED
- Device Name
- Mesh Nebulizer EUDAMED
- Model / Reference
- AE-01、 AE-02 、AE-03 EUDAMEDAE-02 EUDAMEDAE-01 EUDAMEDAE-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976409251128 EUDAMED06976409251111 EUDAMED06976409251135 EUDAMED
- Basic UDI-DI
- 6976409250101BT EUDAMED
- Direct Marketing DI
- 06976409251128 EUDAMED06976409251111 EUDAMED06976409251135 EUDAMED
- EMDN Code
- Z12040210 ULTRASONIC NEBULISERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Mesh Nebulizer by Aerosoon Medical Co., Ltd. — 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 | 6976409250101BT | Class IIa | Active |
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Manufacturer
- Manufacturer
- Aerosoon Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000035439
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (3)
- EUDAMED b01fd4b0-8794-4bb9-9ac8-485a371b6798 61 fields · synced Jul 16, 2026
- EUDAMED 04932bed-9fa1-438f-967a-f2c8b4af54e0 61 fields · synced May 17, 2026
- EUDAMED fb2b8e5b-02e4-4ed2-aa31-1f8978cf2f3e 61 fields · synced May 18, 2026