Identity
- Trade Name
- AGU N3 EUDAMEDCOMPRESSOR NEBULIZER AGU N3 EUDAMED
- Device Name
- Aerosoltherapy Nebulizer EUDAMED
- Model / Reference
- 93053 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970229253225 EUDAMED
- Basic UDI-DI
- 697022925GCE8XXEM EUDAMED
- EMDN Code
- Z12159002 AEROSOL EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Bulgaria 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
Agu N3 by Globalcare Medical 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 | 697022925GCE8XXEM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Globalcare Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000033595
- Authorised Representative
- Donawa Lifescience Consulting Srl IT-AR-000007785
Sources (2)
- EUDAMED 96953323-9317-49e5-b808-b2d40781cb08 61 fields · synced Jul 21, 2026
- EUDAMED 68fcd560-fb7e-4b96-8aa9-8c49600987b0 61 fields · synced Jul 21, 2026