BCS XP System
by Siemens Healthcare Diagnostics Products GmbH United States EUDAMED
Ref 11240019Model IVDR_27_MAR EB_A_INST_BCS_XP
EMDN W0202020102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number0405686900894WE | Date13 Jul 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- IVDR_27_MAR Eb_a_inst_bcs_xp
- Model / Reference
- IVDR_27_MAR EB_A_INST_BCS_XP, 11240019
- Primary DI / UDI-DI
- 00630414002828
- Basic UDI-DI
- 0405686900894WE
- EMDN Code
- W0202020102 Automated coagulometers
- Device Class
- Class A
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000005039
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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 00630414002828|0405686900894WE