Identity
- Trade Name
- Nebulizer kit EUDAMED
- Device Name
- Nebulizer kit EUDAMED
- Model / Reference
- A-DA01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947832500794 EUDAMED
- Basic UDI-DI
- 69478325NKXX2024010800Z6 EUDAMED
- Direct Marketing DI
- 06947832500794 EUDAMED
- EMDN Code
- Z12159085 VARIOUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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 kit by Shenzhen Aeon Technology 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 | 69478325NKXX2024010800Z6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Aeon Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012690
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 8eb21540-c87f-469f-83cc-9b660212603d 61 fields · synced Jun 17, 2026