Identity
- Trade Name
- Mesh Nebulizer EUDAMED
- Device Name
- Mesh Nebulizer EUDAMED
- Model / Reference
- NE-M01, NE-M01L EUDAMEDNE-M01L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945040105558 EUDAMED
- Basic UDI-DI
- 69450401NE-M01BK EUDAMED
- Direct Marketing DI
- 06945040105558 EUDAMED
- EMDN Code
- Z12040210 ULTRASONIC NEBULISERS 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Mesh Nebulizer by Contec Medical Systems 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 | 69450401NE-M01BK | Class IIa | Active |
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Manufacturer
- Manufacturer
- Contec Medical Systems Co., Ltd.
- EUDAMED SRN
- CN-MF-000007715
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED 7cec8389-3e13-402e-b1d1-2a0168867daa 61 fields · synced Jul 19, 2026