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EUDAMED last updated this device on Apr 10, 2026
B-06978198482127D-Dimer Test Kit (Immunofluorescence) is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
069781984821272212CN-MF-000046524(01)06978198482127
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Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Primary placement in Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01021399CARDIAC MARKERS - OTHERPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →IVDR risk classes
IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
No 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-06978198482134On the marketCreatine Kinase-MB (CK-MB) Test Kit (Immunofluorescence)B-06978198482226On the marketCreatine Kinase-MB / High-sensitivity Cardiac Troponin I / Myoglobin ( CK-MB/Hs-cTnI/Myo) Test Kit (Immunofluorescence)B-06978198482097On the marketEstradiol (E2) Test Kit (Immunofluorescence)B-06978198482240On the marketFerritin Test Kit (Immunofluorescence)B-06978198482189On the marketFluorescence immunoassay analyzer69781984802001A4On the market