Ventilator
by Shenzhen Prunus Medical Co., Ltd. 2 variants
Ref 0307Model Padus 6, Padus 7, Padus 8, Padus 5, Padus 5 Pro, Padus 5m, PN50, PN55, PN60, PN65
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 | Number697298001ventilatorPBAZ | Date29 Jan 2023 | 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- Withdrawn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
- Ventilator
- Model / Reference
- Padus 6, Padus 7, Padus 8, Padus 5, Padus 5 Pro, Padus 5m, PN50, PN55, PN60, PN65, 0307
- Primary DI / UDI-DI
- 06972980010185, 06972980010178, 06972980011458, 06972980010871, 06972980011427, 06972980011434, 06972980010604
- Basic UDI-DI
- 697298001ventilatorPBAZ
- EMDN Code
- Z1203010504 Adult and paediatric/neonatal pulmonary ventilators
- Device Class
- Class IIb
- EU market of registration
- Austria
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 (13)
- 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
- Measuring Function: No
- Incorporates Medicinal Product: No