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EUDAMED last updated this device on May 12, 2026
B-06974566304060NTM Identification and Differentiation Detection Kit(Fluorescence PCR Melting Curve Analysis) is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Zhuhai Encode Medical Engineering Co., Ltd.. Placed on the EU market in Denmark. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06974566304060B-06974566304060PNTM048(01)06974566304060
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105010703MYCOBACTERIAL DETECTION BY NA REAGENTSNo certificate specifically references this device's Basic UDI-DI.
Primary placement in Denmark; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| DenmarkPrimary placement | May 26, 2022 | Dec 30, 2027 |
CN-MF-000019361No 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.