nCannula Kit, #0 w/nBonnet
Ref AN0075Model (G) Bubble CPAP System
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 | Number471081008NNGN95 04710810103872 | Date11 Mar 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- Withdrawn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
- nCannula Kit
- Model / Reference
- (G) Bubble CPAP System, AN0075
- Primary DI / UDI-DI
- 04710810103872
- Basic UDI-DI
- 471081008NNGN95
- EMDN Code
- R02010401 Cpap circuits
- Device Class
- Class IIa
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- TW-MF-000022411
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from GaleMed Corporation
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