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Positive Airway Pressure Units
EUDAMEDClass IIa (EU MDR)
Ref C301005Model YH-350, YH-550
Identity
- Trade Name
- Positive Airway Pressure Units EUDAMED
- Device Name
- Positive Airway Pressure Units EUDAMED
- Model / Reference
- YH-350, YH-550 EUDAMEDC301005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06922166513078 EUDAMED
- Basic UDI-DI
- 69221665YHC003L8 EUDAMED
- Direct Marketing DI
- 06922166513078 EUDAMED
- EMDN Code
- Z12030102 CONTINUOUS POSITIVE PRESSURE EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Positive Airway Pressure Units 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 | 69221665YHC003L8 | 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 c223088b-c4a8-4dc9-a17f-c8d429017e5f 61 fields · synced Jun 19, 2026