- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Mar 15, 2024
B-05904365620185Standard anti-D MIKRO (1x2ml) is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Annex II List B. 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.
05904365620185910/1PL-MF-0000376421434-IVDD-161/2022(01)05904365620185
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0103030499IMMUNOHAEMATOLOGY CONTROLS - OTHERPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →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.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
B-05904365620154On the marketStandard anti-D (1x2ml)B-05904365620161On the marketStandard anti-D MIKRO (10x2ml)B-05904365620178On the marketStandardized Red Blood Cells for the ABO group systemB-05904365620079On the marketStandardized Red Blood Cells. Set type LISS-VERA for the antibodies detectionB-05904365620086On the marketStandardized Red Blood Cells. Set type PBS-VERA for the ABO system definitionB-05904365620062On 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.