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EUDAMED last updated this device on May 25, 2026
697637475052BFluorescence Immunoassay Analyzer is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by BIOBASE POCT CO.,LTD. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06976374750510697637475052BBKP2000(01)06976374750510
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.
W0201020102AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)No certificate specifically references this device's Basic UDI-DI.
Primary placement in Germany; available across 1 country total.
Placed on the market in Germany; per-country availability dates not published.
CN-MF-000045945No 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-06976374750473On the market25-Hydroxy Vitamin D (25-OH-VD) Test Kit (Fluorescence immunochromatography method)B-06976374750466On the market25-Hydroxy Vitamin D (25-OH-VD) Test Kit (Fluorescence immunochromatography method)B-06976374750459On the market6-Monoacetylmorphine Test Kit (Colloidal Gold)B-06976374752620On the marketAlpha Fetoprotein (AFP)TestKit（Fluorescence immunochromatography method）B-06976374751722On the market