Humming Vue
Ref 10010701001
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 | Number458029509150DN 04580295091519 | Date30 May 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- Withdrawn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
- Artificial Ventilator
- Model / Reference
- 10010701001
- Primary DI / UDI-DI
- 04580295091519
- Basic UDI-DI
- 458029509150DN
- EMDN Code
- Z1203010503 Neonatal/paediatric pulmonary ventilators
- Device Class
- Class IIb
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- JP-MF-000038066
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Metran 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