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Nasal Mask
EUDAMEDClass IIa (EU MDR)
Ref MN02015Model YN-01, YN-02, YN-03, YN-03T, YN-05, YN-06, YN-02A, YN-03A, YN-03TA , YN-03TH, YN-06H
Identity
- Trade Name
- Nasal Mask EUDAMED
- Device Name
- Sleep apnea breathing therapy mask EUDAMED
- Model / Reference
- YN-01, YN-02, YN-03, YN-03T, YN-05, YN-06, YN-02A, YN-03A, YN-03TA , YN-03TH, YN-06H EUDAMEDMN02015 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06922166514754 EUDAMED
- Basic UDI-DI
- 69221665YNM001QC EUDAMED
- EMDN Code
- R0301010201,R0301010202 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Nasal Mask by Suzhou Yuyue 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 | 69221665YNM001QC | Class IIa | Active |
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Manufacturer
- Manufacturer
- Suzhou Yuyue Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000015854
- Authorised Representative
- Metrax GmbH DE-AR-000005481
Sources (1)
- EUDAMED ba7fb3af-e245-40ce-ba73-251475771e39 61 fields · synced Oct 5, 2026