- Role
- Country
- Date of registration
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PL-MF-0000376421434-IVDD-160/20221434-IVDD-159/2022Preserved Standard Red Blood Cells. Set for the ABO system definition is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Annex II List A. Manufactured by Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach. Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Feb 12, 2024
B-05904365620017Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)05904365620017
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Primary placement in Poland; available across 1 country total.
Placed on the market in Poland; per-country availability dates not published.
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
05904365620017Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-05904365620017508UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
IVDR risk classes
IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0103030101ABO GROUPING CELLSNo certificate specifically references this device's Basic UDI-DI.
B-05904365620215On the marketPolyvalent anti-human globulin serum (10x5ml)B-05904365620192On the marketPolyvalent anti-human globulin serum (1x5ml)B-05904365620208On the marketPreserved Standard Red Blood Cells. Set for the ABO system definition IB-05904365620024On the marketPreserved Standard Red Blood Cells. Set for the antibodies detectionB-05904365620031On the marketPreserved Standard Red Blood Cells. Set for the antibody identificationB-05904365620048On the marketNo certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.