Identity
- Trade Name
- NEB400 EUDAMED
- Device Name
- Aerosoltherapy Nebulizer EUDAMED
- Model / Reference
- 9B-0NEB400-006 EUDAMEDp957400-3 EUDAMEDp957400-4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970229252440 EUDAMED06970229252396 EUDAMED06970229251993 EUDAMED
- Basic UDI-DI
- 697022925GCE8XXEM EUDAMED
- EMDN Code
- Z12159002 AEROSOL EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMEDPoland 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
Neb400 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 (3)
- EUDAMED fd45b924-7f2c-4ad1-b8fc-6e12523207cd 61 fields · synced Jul 23, 2026
- EUDAMED 32b3ac05-fe95-42ef-95a5-c68187d47611 61 fields · synced May 18, 2026
- EUDAMED 8ed2fb90-c29a-499b-9db6-de8281ef93f4 61 fields · synced May 19, 2026