Konserwowane Krwinki Wzorcowe do układu ABO I
by Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach Poland EUDAMED
Ref 576
EMDN W0103030101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberB-05904365620024 | Date12 Feb 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Preserved Standard Red Blood Cells. Set for the ABO system definition I
- Model / Reference
- 576
- Primary DI / UDI-DI
- 05904365620024
- Basic UDI-DI
- B-05904365620024
- EMDN Code
- W0103030101 Abo grouping cells
- Device Class
- Class IVD Annex II List A
- 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 de80b519-aca6-4170-bd6a-77002996c28b