Identity
- Trade Name
- Mesh Nebulizer EUDAMED
- Device Name
- Mesh Nebulizer EUDAMED
- Model / Reference
- NE-M01, NE-M01L EUDAMEDNE-M01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945040103349 EUDAMED
- Basic UDI-DI
- 69450401NE-M01BK EUDAMED
- Direct Marketing DI
- 06945040103349 EUDAMED
- EMDN Code
- Z12040210 ULTRASONIC NEBULISERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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 8be8449f-dfaa-4002-8c70-a78ed343072e 61 fields · synced Jun 19, 2026