Standard Human Plasma
by Siemens Healthcare Diagnostics Products GmbH United States EUDAMED
Ref 10873908Model IVDR_27_MAR EB_C_PROF_REAG_SHP
EMDN W0103020701
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number0405686900193V9 | Date15 Jun 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- IVDR_27_MAR Eb_c_prof_reag_shp
- Model / Reference
- IVDR_27_MAR EB_C_PROF_REAG_SHP, 10873908
- Primary DI / UDI-DI
- 00630414639789
- Basic UDI-DI
- 0405686900193V9
- Unit of Use DI
- 00630414304816
- EMDN Code
- W0103020701 Calibration plasma for haemostasis
- Device Class
- Class C
- 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 (8)
- Sterile: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 00630414639789|0405686900193V9