Identity
- Trade Name
- NEB200 EUDAMED
- Device Name
- Aerosoltherapy Nebulizer EUDAMED
- Model / Reference
- p957200-3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970229252242 EUDAMED
- Basic UDI-DI
- 697022925GCE8XXEM EUDAMED
- EMDN Code
- Z12159002 AEROSOL EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania 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
Neb200 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 (1)
- EUDAMED 18649010-d67e-4576-b209-105670de1ca3 61 fields · synced Jun 18, 2026