- Role
- Country
- Date of registration
- Address
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.β2-MICROGLOBULIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY） 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.
EUDAMED last updated this device on Apr 21, 2026
B-06942202215834Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)06942202215834
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 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 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
06942202215834Basic 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-069422022158343023552UDI 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.
W0102019099SPECIFIC PROTEINS - OTHERB-06925794518248On the marketβ2-MICROGLOBULIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）B-06942202259456On the marketβ2-MICROGLOBULIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）B-06942202261589On the marketβ2-MICROGLOBULIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）B-06925794592095On the marketβ2-MICROGLOBULIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）B-06942202215841On the marketβ2-MICROGLOBULIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）B-06925794592088On the marketNo certificate specifically references this device's Basic UDI-DI.