LUCIA Cytogenetics, version 4.2
Active
CE IVDR
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/IVDR | Number859421158LCGQC 08594211580014 | Date4 Jun 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- LUCIA Cytogenetics
- Primary DI / UDI-DI
- 08594211580014
- Basic UDI-DI
- 859421158LCGQC
- EMDN Code
- W0202050392 Laboratory instruments for microscopic investigations - IVD medical device software
- Device Class
- Class C
- Special Device Type
- Software
- EU market of registration
- Czechia
Manufacturer details
- EUDAMED SRN
- CZ-MF-000025008
Properties
Other properties (10)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No