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JP-MF-000024143CL AIA-PACK CMV IgM TEST CUP is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class C. Manufactured by Tosoh Corporation. Placed on the EU market in Belgium. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 27, 2026
45601892100010717FPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)14560189216003
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
12 warnings recorded — scroll inside the panel to see all entries.
OTHER
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 Belgium; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| BelgiumPrimary placement | — | Still on market |
| Austria | — | Still on market |
| Bulgaria | — | Still on market |
| Cyprus | — | Still on market |
| Czechia | — | Still on market |
| Germany | — | Still on market |
| Denmark | — | Still on market |
| Estonia | — | Still on market |
| EL | — | Still on market |
| Spain | — | Still on market |
| Finland | — | Still on market |
| France | — | Still on market |
| Croatia | — | Still on market |
| Hungary | — | Still on market |
| Ireland | — | Still on market |
| Iceland | — | Still on market |
| Italy | — | Still on market |
| Liechtenstein | — | Still on market |
| Lithuania | — | Still on market |
| Luxembourg | — | Still on market |
| Latvia | — | Still on market |
| Malta | — | Still on market |
| Netherlands | — | Still on market |
| Norway | — | Still on market |
| Poland | — | Still on market |
| Portugal | — | Still on market |
| Romania | — | Still on market |
| Sweden | — | Still on market |
| Slovenia | — | Still on market |
| Slovakia | — | Still on market |
| Türkiye | — | Still on market |
| XI | — | 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.
14560189216003Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
45601892100010717F0029161UDI 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.
W0105040204CMV IGM45601892100040017FOn the marketAutomated TRCR Real-time Monitor TRCReady-8045601892100040037KOn the marketCL AIA-PACK CMV IgM ADJUSTER SET45601892100010717FOn the marketCL AIA-PACK DETECTOR STANDARDIZATION CUP456018921000100674On the marketCL AIA-PACK DILUENT CONCENTRATE456018921000100572On the marketCL AIA-PACK DILUENT CONCENTRATE456018921000100572On the marketNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
HX 2048822-1SupplementedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
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