Bgi
by Bgi Europe a/S Denmark EUDAMED
Ref EU0200050002 (PBC20A)Model PBC20， PBC20A， PBC22， PBC22A，PBC20 Plus, PBC20A Plus，PBC22 Plus，PBC22A Plus
EMDN W0201010102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number5745000468EU02000500019R | Date17 Jan 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Automated clinical chemistry analyzer
- Model / Reference
- PBC20， PBC20A， PBC22， PBC22A，PBC20 Plus, PBC20A Plus，PBC22 Plus，PBC22A Plus, EU0200050002 (PBC20A)
- Primary DI / UDI-DI
- 05745000468423
- Basic UDI-DI
- 5745000468EU02000500019R
- EMDN Code
- W0201010102 CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
- Device Class
- Class A
- Market of Registration
- Denmark
Manufacturer details
- EUDAMED SRN
- DK-MF-000014089
Other devices from Bgi Europe a/S
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 82ea65e0-dfa0-4813-9c6b-7da521f0a1f8