Standaryzowane Krwinki Wzorcowe O RhD+ opłaszczone przeciwciałami anty-D
by Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach Poland EUDAMED
Ref 515
EMDN W0103030401
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-05904365620109 | Date15 Mar 2024 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/IVDD Expiring (legacy directive)
Specification
- Device Name
- Coated Standardized Red Blood Cells ORhD+ with anti-D antibodies
- Model / Reference
- 515
- Primary DI / UDI-DI
- 05904365620109
- Basic UDI-DI
- B-05904365620109
- EMDN Code
- W0103030401 Coombs control cells
- Device Class
- Class IVD Annex II List B
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- PL-MF-000037642
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Properties & raw data
Show properties, registry sources and raw records
Other properties (7)
- Sterile: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED ff0b6a2e-7f59-49a1-9a8f-e87637a6390e