Full Face Mask
by Suzhou Yuyue Medical Technology Co., Ltd. EUDAMED
Active
Ref MM03001Model YF-01, YF-02, YF-03, YF-05, YF-06, YF-RT01, YF-RT02, YF-RT03, YF-01A, YF-02A, YF-02X
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69221665YFM001ML | Date7 Mar 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Sleep Apnea Breathing Therapy Mask
- Model / Reference
- YF-01, YF-02, YF-03, YF-05, YF-06, YF-RT01, YF-RT02, YF-RT03, YF-01A, YF-02A, YF-02X, MM03001
- Primary DI / UDI-DI
- 06922166510916
- Basic UDI-DI
- 69221665YFM001ML
- EMDN Code
- R0301010201,R0301010202
- Device Class
- Class IIa
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000015854
- Authorised representative
- Metrax GmbH DE-AR-000005481
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Properties
Show properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No