Positive Airway Pressure Units
by Suzhou Yuyue Medical Technology Co., Ltd. EUDAMED
Active
Ref C501002Model ET3, ET5, ET5 Elite, ET5 Pro, ET6, ET6 Elite
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69221665YHC005LC | Date21 Oct 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- ET3, ET5, ET5 Elite, ET5 Pro, ET6, ET6 Elite, C501002
- Primary DI / UDI-DI
- 06922166513375
- Basic UDI-DI
- 69221665YHC005LC
- Direct Marketing DI
- 06922166513375
- EMDN Code
- Z12030102 Continuous positive pressure equipment
- Device Class
- Class IIa
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000015854
- Authorised representative
- Metrax GmbH DE-AR-000005481
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Properties
Other properties (12)
- 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
- Incorporates Medicinal Product: No