Positive Airway Pressure Unit
by Shenzhen Prunus Medical Co., Ltd. 3 variants
Ref 0307Model Q20C, Q20A, Q20AW, Q20A PRO, Q25B, Q25B W, Q25B PRO, Q25ST, Q25ST PRO, Q30ST, Q30STW, Q30ST PRO, Q30 LAB
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697298001ventilatorQ7Y | Date10 Jul 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Positive Airway Pressure Unit
- Model / Reference
- Q20C, Q20A, Q20AW, Q20A PRO, Q25B, Q25B W, Q25B PRO, Q25ST, Q25ST PRO, Q30ST, Q30STW, Q30ST PRO, Q30 LAB, 0307
- Primary DI / UDI-DI
- 06972980011243, 06972980011168, 06972980011144, 06972980011182, 06972980011137, 06972980011205, 06972980011267, 06972980010246, 06972980011250
- Basic UDI-DI
- 697298001ventilatorQ7Y
- EMDN Code
- Q03010299 Antisnoring and obstructive sleep apnoea devices - other
- Device Class
- Class IIa
- EU market of registration
- AustriaNorthern Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000002498
- Authorised representative
- Wellkang Ltd XI-AR-000001836
Other devices from Shenzhen Prunus Medical Co., Ltd.
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