- Role
- Country
- Date of registration
- Address
DE-MF-000026925No 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.AESKUBLOTS® Allergy SEVEN is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Aesku.Diagnostics GmbH & Co. KG. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jun 2, 2026
B-04250289512251Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)04250289512251
1 warning recorded — scroll inside the panel to see all entries.
CW010Sterile
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 18 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | Still on market |
| Austria | — | Still on market |
| Belgium | — | Still on market |
| Cyprus | — | Still on market |
| Spain | — | Still on market |
| Finland | — | Still on market |
| France | — | Still on market |
| Croatia | — | Still on market |
| Ireland | — | Still on market |
| Italy | — | Still on market |
| Liechtenstein | — | Still on market |
| Luxembourg | — | Still on market |
| Latvia | — | Still on market |
| Malta | — | Still on market |
| Netherlands | — | Still on market |
| Poland | — | Still on market |
| Romania | — | Still on market |
| Slovenia | — | 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.
04250289512251Basic 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-04250289512251421407.BULK.120UDI 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.
W01020204IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AGNo certificate specifically references this device's Basic UDI-DI.
B-04250289512190On the marketAESKUBLOTS® Allergy ONEB-04250289510400On the marketAESKUBLOTS® Allergy SEVENB-04250289510738On the marketAESKUBLOTS® Allergy SIXB-04250289512244On the marketAESKUBLOTS® Allergy SIXB-04250289510721On the marketAESKUBLOTS® Allergy TENB-04250289510899On the market