← Back to catalogue
Positive Airway Pressure Units
EUDAMEDClass IIa (EU MDR)
Ref C101001Model YH-360, YH-560, YH-580
Identity
- Trade Name
- Positive Airway Pressure Units EUDAMED
- Device Name
- Positive Airway Pressure Units EUDAMED
- Model / Reference
- YH-360, YH-560, YH-580 EUDAMEDC101001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06922166500061 EUDAMED
- Basic UDI-DI
- 69221665YHC001L4 EUDAMED
- Direct Marketing DI
- 06922166500061 EUDAMED
- EMDN Code
- Z12030102 CONTINUOUS POSITIVE PRESSURE EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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 | 69221665YHC001L4 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Suzhou Yuyue Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000015854
- Authorised Representative
- Metrax GmbH DE-AR-000005481
Sources (1)
- EUDAMED a9904d90-7697-4d52-8cce-b2c681eb00eb 61 fields · synced Jun 18, 2026