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EUDAMED last updated this device on May 12, 2026
B-CNMF000054349DP017GHMQL Rapid Test Kit (Colloidal gold method) is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Synthgene (Yixing) Health Technology Co., Ltd.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
D-CNMF000054349DP017GHB-CNMF000054349DP017GHDP017D-CNMF000054349DP017GH
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102160599DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHERNo certificate specifically references this device's Basic UDI-DI.
Primary placement in Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Still on market |
CN-MF-000054349No 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-CNMF000054349DP004G8On the market6-MAM Rapid Test Kit (Colloidal gold method)B-CNMF000054349DP018GKOn the marketALC Rapid Test Kit (Colloidal gold method)B-CNMF000054349DP019GMOn the marketAMP Rapid Test Kit(Colloidal gold method)B-CNMF000054349DP001G2On the marketAPAP Rapid Test Kit (Colloidal gold method)B-CNMF000054349DP028GNOn the market