eXciteOSA
by Signifier Medical Technologies Limited
Ref eXciteOSA system trade pack (starter pack)
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 | Number50606274800086 05060627480048 | Date11 Oct 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- Withdrawn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
- Model / Reference
- eXciteOSA system trade pack (starter pack)
- Primary DI / UDI-DI
- 05060627480048
- Basic UDI-DI
- 50606274800086
- Direct Marketing DI
- 05060627480048
- EMDN Code
- Q03010299 Antisnoring and obstructive sleep apnoea devices - other
- Device Class
- Class IIa
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- GB-MF-000035054
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from Signifier Medical Technologies, 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