KENZA ONE - AUTOMATIC BIOCHEMISTRY ANALYSER, including accessories
by Biolabo France EUDAMED
Ref KENZA ONE EMDN W0201010101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number376017308K1QX | Date30 Aug 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Kenza One
- Model / Reference
- KENZA ONE
- Primary DI / UDI-DI
- 03760173087372
- Basic UDI-DI
- 376017308K1QX
- Direct Marketing DI
- 03760173087372
- EMDN Code
- W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
- Device Class
- Class A
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- FR-MF-000001633
Other devices from Biolabo
Properties & raw data
Show properties, registry sources and raw records
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- New Device: No
Sources (1)
- EUDAMED a5bcdf19-76bb-4184-8147-92b6ffec34ce