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EUDAMED last updated this device on May 26, 2026
B-hs-cTnI/CK-MB63hs-cTnI/CK-MB (CLIA) is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by DROPHIL BIOTECH (SHENZHEN) COMPANY LIMITED. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
D-hs-cTnI/CK-MB63B-hs-cTnI/CK-MB6348 tests/kit:(Excluding calibrators and controls)/(Including calibrators)/(Including calibrators and controls)D-hs-cTnI/CK-MB63
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01021306TROPONIN I/T1 warning recorded — scroll inside the panel to see all entries.
CW010No 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-000042193No 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.