- 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.CS-ISE Detergent is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. 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 May 15, 2026
69257945W01010399R02CPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)06925794577153
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.
CW018Sterile
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.
06925794577153Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
69257945W01010399R02C3019956UDI 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.
W01010399ELECTROLYTES - OTHERNo certificate specifically references this device's Basic UDI-DI.
69257945W01019099R04YOn the marketCS-Anti-Bacterial Phosphor-Free Detergent69257945W01019099R04YOn the marketCS-ISE Detergent69257945W01010399R02COn the marketCYSTATIN C REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）B-06942202216107On the marketCYSTATIN C REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）B-06925794592521On the marketCYSTATIN C REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）B-06942202216091On the market