Keros
Ref KEROS
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 | Number376033208KEROS9B | Date6 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- Withdrawn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
- KEROS
- Primary DI / UDI-DI
- 03760332080008, 03760332080039
- Basic UDI-DI
- 376033208KEROS9B
- EMDN Code
- Z11069092 Various digital bioimaging management instruments - medical device software
- Device Class
- Class IIa
- Special Device Type
- Software
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- FR-MF-000007545
Other devices from Incepto Medical SAS
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