Standaryzowane Krwinki Wzorcowe typ PBS-VERA do układu ABO
by Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach
Ref 511
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-05904365620062 05904365620062 | Date12 Feb 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Device Name
- Standardized Red Blood Cells. Set type PBS-VERA for the ABO system definition
- Model / Reference
- 511
- Primary DI / UDI-DI
- 05904365620062
- Basic UDI-DI
- B-05904365620062
- EMDN Code
- W0103030101 Abo grouping cells
- Device Class
- Class IVD Annex II List A
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- PL-MF-000037642
Other devices from Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach
See all devices from Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach →
Properties
Other properties (7)
- Sterile: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No