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EUDAMED last updated this device on May 15, 2026
697846523ProteinC01RDCytokeratin-19 Assay kit(Chemiluminescence Immunoassay Method） is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class C. Manufactured by Shenzhen Dake Medical Technology Co.,Ltd. Placed on the EU market in Austria. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06978465235715697846523ProteinC01RD50 tests(01)06978465235715
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.
W0102030126CYTOKERATINSNo 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-000047336No 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.697846523VitaminB01LBOn the market25-hydroxy Vitamin D Assay kit(Chemiluminescence Immunoassay Method）697846523VitaminB01LBOn the market25-hydroxy Vitamin D Assay kit(Chemiluminescence Immunoassay Method）697846523VitaminB01LBOn the market25-hydroxy Vitamin D Assay kit(Chemiluminescence Immunoassay Method）697846523VitaminB01LBOn the market25-hydroxy Vitamin D Assay kit(Chemiluminescence Immunoassay Method）697846523VitaminB01LBOn the market