- Role
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- Date of registration
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EUDAMED last updated this device on Feb 22, 2026
B-01.242-03CMAnti-Leb for card method monoclonal, human clone: P3F234MD4 is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by ANTITOXIN GmbH. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
DE-MF-000008156D-01.242-03CM
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
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 Germany; available across 9 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | Still on market |
| Austria | — | Still on market |
| EL | — | Still on market |
| Spain | — | Still on market |
| France | — | Still on market |
| Italy | — | Still on market |
| Norway | — | Still on market |
| Portugal | — | Still on market |
| Sweden | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
D-01.242-03CMBasic 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-01.242-03CM01.242-03UDI 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.
W0103030501OTHER ANTIGEN TYPING REAGENTSPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →B-01.244-02CZOn the marketAnti-K (KEL1) Coombs-reactive, polyclonal, humanB-04250861802312On the marketAnti-K (KEL1) monoclonal, human IgM clone: MS-56B-04250861802114On the marketAnti-M for card method monoclonal, mouse clone: LM110/1404250861801.179KYOn the marketAnti-M for card method monoclonal, mouse Clone: LM110/1404250861801.179KYOn the marketAnti-P1 for card method monoclonal, human IgM clone: P3NIL100B-01.243-03CUOn 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.No certificate specifically references this device's Basic UDI-DI.