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EUDAMED last updated this device on May 13, 2026
697468962522SADigital PCR Universal Kit is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by TargetingOne Technology (Beijing) Corporation. Placed on the EU market in Austria. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06974689625226697468962522SA10132(01)06974689625226
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.
W010699GENETIC TESTS - OTHERNo certificate specifically references this device's Basic UDI-DI.
Primary placement in Austria; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| AustriaPrimary placement | Still on market |
CN-MF-000028247No 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-06974689626131On the marketALK/ROS1/MET gene fusions and mutations digital PCR detection kitB-06974689627121On the marketAML1-ETO digital PCR detection kitB-06974689626759On the marketAML1-ETO digital PCR detection kitB-06974689627459On the marketBCR-ABL p190 digital PCR detection kitB-06974689627060On the market