- Role
- Country
- Date of registration
- Address
DE-MF-000008156AHG serum blend 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.
EUDAMED last updated this device on Jul 22, 2026
B-04250861805337Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)04250861805337
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 25 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Jan 1, 2020 | Still on market |
| Austria | Jan 1, 2020 | Still on market |
| Bulgaria | Jan 1, 2020 | Still on market |
| Czechia | Jan 1, 2020 | Still on market |
| Denmark | Jan 1, 2020 | Still on market |
| Estonia | Jan 1, 2020 | Still on market |
| EL | Jan 1, 2020 | Still on market |
| Spain | Jan 1, 2020 | Still on market |
| Finland | Jan 1, 2020 | Still on market |
| France | Jan 1, 2020 | Still on market |
| Hungary | Jan 1, 2020 | Still on market |
| Ireland | Jan 1, 2020 | Still on market |
| Italy | Jan 1, 2020 | Still on market |
| Lithuania | Jan 1, 2020 | Still on market |
| Latvia | Jan 1, 2020 | Still on market |
| Netherlands | Jan 1, 2020 | Still on market |
| Norway | Jan 1, 2020 | Still on market |
| Poland | Jan 1, 2020 | Still on market |
| Portugal | Jan 1, 2020 | Still on market |
| Romania | Jan 1, 2020 | Still on market |
| Sweden | Jan 1, 2020 | Still on market |
| Slovenia | Jan 1, 2020 | Still on market |
| Slovakia | Jan 1, 2020 | Still on market |
| Türkiye | Jan 1, 2020 | Still on market |
| XI | Jan 1, 2020 | 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.
04250861805337Basic 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-0425086180533703.140-10UDI 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.
W0103030304POLYSPECIFIC ANTIHUMAN SERUMB-04250861821283On the marketABO-trol® forte II or Medtrokarte NK4B-04250861821276On the marketABO-trol® forte plusB-04250861821283On the marketAnti-A monoclonal, IgM clone: Birma-1B-04250861800110On the marketAnti-A1 for card method Lectin (Dolichos biflorus)B-04250861815404On the marketAnti-AB monoclonal, IgM clones: ES-15, ES-4B-04250861800318On the marketNo certificate specifically references this device's Basic UDI-DI.
No 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.