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EUDAMED last updated this device on May 21, 2026
697798188015WFully Automatic Quantum Dot Fluorescence Immunochromatographic Analyzer is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Chongqing Juce Life Health Technology Co., Ltd.. Placed on the EU market in Austria. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06977981880263697798188015WJ3-E(01)06977981880263
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W02010299IMMUNOCHEMISTRY INSTRUMENTS - OTHERNo 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-000053774No 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-06977981880324On the marketBlood Glucose/Blood Ketone/Uric Acid/Blood Lipids Test Kit (Electrochemical and Dry Chemistry Methods)B-06977981880164On the marketCardiac Troponin I/Creatine Kinase-MB/Myoglobin Test Kit (QDs-FICA)B-06977981880157On the marketD-Dimer/FDP Test Kit (QDs-FICA)B-06977981880003On the marketFully Automatic Multi-functional Analyzer697798188025YOn the market