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DE-MF-000008156Anti-Wr(a) monoclonal IgG is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class C. Manufactured by ANTITOXIN GmbH. Placed on the EU market in Austria. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jun 3, 2026
4250861801.255KPPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)04250861821535
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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 Austria; available across 24 countries total.
| Country | On market since | Until |
|---|---|---|
| AustriaPrimary placement | Jun 10, 2026 | Still on market |
| Bulgaria | Jun 10, 2026 | Still on market |
| Czechia | Jun 10, 2026 | Still on market |
| Germany | Jun 10, 2026 | Still on market |
| Denmark | Jun 10, 2026 | Still on market |
| Estonia | Jun 10, 2026 | Still on market |
| EL | Jun 10, 2026 | Still on market |
| Spain | Jun 10, 2026 | Still on market |
| Finland | Jun 10, 2026 | Still on market |
| France | Jun 10, 2026 | Still on market |
| Hungary | Jun 10, 2026 | Still on market |
| Italy | Jun 10, 2026 | Still on market |
| Lithuania | Jun 10, 2026 | Still on market |
| Latvia | Jun 10, 2026 | Still on market |
| Netherlands | Jun 10, 2026 | Still on market |
| Norway | Jun 10, 2026 | Still on market |
| Poland | Jun 10, 2026 | Still on market |
| Portugal | Jun 10, 2026 | Still on market |
| Romania | Jun 10, 2026 | Still on market |
| Sweden | Jun 10, 2026 | Still on market |
| Slovenia | Jun 10, 2026 | Still on market |
| Slovakia | Jun 10, 2026 | Still on market |
| Türkiye | Jun 10, 2026 | Still on market |
| XI | Jun 10, 2026 | 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.
04250861821535Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
4250861801.255KP01.255-02UDI 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.
W01030399IMMUNOHAEMATOLOGY (BLOOD GROUPING) TESTS - OTHERNo certificate specifically references this device's Basic UDI-DI.
B-01.243-03CUOn the marketAnti-Wr(a) monoclonal IgG4250861801.255KPOn the marketAnti-Wr(a) monoclonal IgG4250861801.255KPOn the marketAnti-Wr(a) monoclonal IgG4250861801.255KPOn the marketControl solution, for monoclonal reagentsB-04250861805917On the marketMedtrokarten NK4B-04250861815381On 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.