Data from EUDAMED, last updated Jun 11, 2026

D-Dimer (DD) Rapid Test Kit (Fluorescence Immunochromatographic Assay)

B-06974464591418

1 reference

IVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk category: IVDD — General
Manufacturer: Guangzhou Decheng Biotechnology Co., Ltd.

Device family identification

Device name: D-Dimer (DD) Rapid Test Kit (Fluorescence Immunochromatographic Assay)
Basic UDI-DI: B-06974464591418
Issuing agency: EUDAMED
Version date: May 13, 2026

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk category: IVDD — General
Status: On the market

ReagentProfessional testingAnimal tissues / cells

European Medical Device Nomenclature — the EU product classifications carried across this device family's references.

References

1 reference

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
D-Dimer (DD) Rapid Test Kit (Fluorescence Immunochromatographic Assay)	`5274C4X025`	`06974464591418`	1	On the market