DiaKwant in combination with navify® Digital Pathology
by DiaDeep EUDAMED
Active
Ref DK-RCE
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number376041391KWANTCK | Date31 Mar 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- DiaKwant
- Model / Reference
- DK-RCE
- Primary DI / UDI-DI
- 03760413910019
- Basic UDI-DI
- 376041391KWANTCK
- Direct Marketing DI
- 03760413910019
- EMDN Code
- W0202050392 Laboratory instruments for microscopic investigations - IVD medical device software
- Device Class
- Class C
- Special Device Type
- Software
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- FR-MF-000043451
Properties
Other properties (11)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No