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EUDAMED last updated this device on May 15, 2026
697484781005Q8ST-360 Microplate Reader is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Shanghai Kehua Laboratory System Co., Ltd.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06974847812505697484781005Q8ST-360(01)06974847812505
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.
W0201020201IMMUNOCHEMISTRY READERSNo certificate specifically references this device's Basic UDI-DI.
Primary placement in Italy; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Still on market |
CN-MF-000017428No 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.697484781001PYOn the marketPolaris c1000 Automatic Clinical Chemistry Analyzer697484781001PYOn the marketPolaris c1100 Automatic Clinical Chemistry Analyzer697484781001PYOn the marketPolaris c2000 Automatic Clinical Chemistry Analyzer697484781001PYOn the marketPolaris c2100 Automatic Clinical Chemistry Analyzer697484781001PYOn the market