- Organization name
- UDI-DI code
- Reference / catalog number
BE-MF-000015341IDS-iSYS Trigger Set is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Immunodiagnostic Systems SA. Placed on the EU market in Belgium. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jun 14, 2022
5425030421024R9Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)05425030421024
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
1 warning recorded — scroll inside the panel to see all entries.
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 28 countries total.
| Country | On market since | Until |
|---|---|---|
| BelgiumPrimary placement | Mar 10, 2009 | Still on market |
| Austria | Mar 10, 2009 | Still on market |
| Bulgaria | Mar 10, 2009 | Still on market |
| Cyprus | Mar 10, 2009 | Still on market |
| Czechia | Mar 10, 2009 | Still on market |
| Germany | Mar 10, 2009 | Still on market |
| Denmark | Mar 10, 2009 | Still on market |
| Estonia | Mar 10, 2009 | Still on market |
| EL | Mar 10, 2009 | Still on market |
| Spain | Mar 10, 2009 | Still on market |
| Finland | Mar 10, 2009 | Still on market |
| France | Mar 10, 2009 | Still on market |
| Croatia | Mar 10, 2009 | Still on market |
| Hungary | Mar 10, 2009 | Still on market |
| Ireland | Mar 10, 2009 | Still on market |
| Italy | Mar 10, 2009 | Still on market |
| Lithuania | Mar 10, 2009 | Still on market |
| Luxembourg | Mar 10, 2009 | Still on market |
| Latvia | Mar 10, 2009 | Still on market |
| Malta | Mar 10, 2009 | Still on market |
| Netherlands | Mar 10, 2009 | Still on market |
| Poland | Mar 10, 2009 | Still on market |
| Portugal | Mar 10, 2009 | Still on market |
| Romania | Mar 10, 2009 | Still on market |
| Sweden | Mar 10, 2009 | Still on market |
| Slovenia | Mar 10, 2009 | Still on market |
| Slovakia | Mar 10, 2009 | Still on market |
| Türkiye | Mar 10, 2009 | 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.
05425030421024Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
5425030421024R9IS-CT100UDI 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.
W0201020185AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLESNo certificate specifically references this device's Basic UDI-DI.
5425030421031R6On the marketIDS-iSYS Cartridge Check System (CCS)5425030426012S5On the marketIDS-iSYS System Liquid (Syst. l)5425030421017RCOn the marketIDS-iSYS Wash Solution (Wash S)5425030421031R6On the marketSystem Liquid 5L5425030421017RCOn the marketTrigger Set5425030421024R9On 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.