SuperNO2VA Et Mask, Adult Medium
by SunMed, LLC EUDAMED
Active
Ref SEM-20-CEModel SuperNO2VA Et Mask and System
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0889483EtSys20035eTY | Date8 Jul 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Specification
- Model / Reference
- SuperNO2VA Et Mask and System, SEM-20-CE
- Primary DI / UDI-DI
- 30889483605695
- Basic UDI-DI
- 0889483EtSys20035eTY
- Unit of Use DI
- 10889483605691
- EMDN Code
- R0301010201 Cpap masks
- Device Class
- Class IIa
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000009164
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Other devices from SunMed
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