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Mesh Nebulizer
EUDAMEDClass IIa (EU MDR)
Ref YS31Model YS30,YS31,YS32,YS33,YS34,YS35,YS36, YS37,YS81,YS82,YS30E,YS31E,YS32E, YS33E,YS34E,YS35E,YS36E,YS37E,YS38E,YS81E,YS82E,YS85E,YS86E
Identity
- Trade Name
- Mesh Nebulizer EUDAMED
- Device Name
- Mesh Nebulizer EUDAMED
- Model / Reference
- YS30,YS31,YS32,YS33,YS34,YS35,YS36, YS37,YS81,YS82,YS30E,YS31E,YS32E, YS33E,YS34E,YS35E,YS36E,YS37E,YS38E,YS81E,YS82E,YS85E,YS86E EUDAMEDYS31 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939313600017 EUDAMED
- Basic UDI-DI
- 69393136MEN01RM EUDAMED
- Direct Marketing DI
- 06939313600017 EUDAMED
- EMDN Code
- R060101 COLD NEBULISATION SYSTEMS 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 Changzhou Zhengyuan 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 | 69393136MEN01RM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Changzhou Zhengyuan Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000017953
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED 57f3335c-521a-4e42-ab16-93d8915b26ae 61 fields · synced Oct 6, 2026