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Full Face Mask
EUDAMEDClass IIa (EU MDR)
Ref MF06021Model YF-01, YF-02, YF-03, YF-05, YF-06, YF-RT01, YF-RT02, YF-RT03, YF-01A, YF-02A, YF-02X
Identity
- Trade Name
- Full Face Mask EUDAMED
- Device Name
- Sleep Apnea Breathing Therapy Mask EUDAMED
- Model / Reference
- YF-01, YF-02, YF-03, YF-05, YF-06, YF-RT01, YF-RT02, YF-RT03, YF-01A, YF-02A, YF-02X EUDAMEDMF06021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06922166514495 EUDAMED
- Basic UDI-DI
- 69221665YFM001ML 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
Full Face 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 | 69221665YFM001ML | 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 db040bb4-2302-4eb4-916b-69ace82dea5b 61 fields · synced May 23, 2026