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EUDAMED last updated this device on May 15, 2026
B-06979469760197Serum Amyloid A Proteins (SAA) Test Kit (Quantum Dots Fluorescence Immunochromatography) is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Nanjing Vazyme Medical Technology Co.,Ltd.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06979469760197B-06979469760197C3402CV(01)06979469760197
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01021199RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER4 warnings recorded — scroll inside the panel to see all entries.
CW010CW009CW032CW007No certificate specifically references this device's Basic UDI-DI.
Primary placement in Spain; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | Still on market |
CN-MF-000031032No 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-06979469761545On the market2019-nCoV IgG/IgM Detection Kit (Colloidal Gold-Based)B-06973315730747On the market2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection KitB-06973315739771On the market2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection KitB-06973315737975On the market25-Hydroxyvitamin D (25-OH-VD) Test KitB-06979469761286On the market