- Role
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- Date of registration
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EUDAMED last updated this device on May 14, 2026
B-06942202226458Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →ISE Reference Solution is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by DIRUI INDUSTRIAL CO., LTD. Placed on the EU market in Austria. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →06942202226458Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →B-069422022264583024564UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →(01)06942202226458
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01010399ELECTROLYTES - OTHERSterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →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.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
Primary placement in Austria; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| AustriaPrimary placement | Still on market | |
| Belgium | 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 |
CN-MF-000001891No 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.B-06925794521804On the marketThyroid Function ControlB-06925794521798On the market5’-NUCLEOTIDASE REAGENT KIT（ENZYME METHOD）B-06925794591906On the market5’-NUCLEOTIDASE REAGENT KIT（ENZYME METHOD）B-06942202215827On the market5’-NUCLEOTIDASE REAGENT KIT（ENZYME METHOD）B-06942202258671On the market