Data from EUDAMED, last updated Jun 12, 2026

Dengue IgG/IgM Test Kit (Colloidal Gold)

697241261IDE-A402EJ

5 references

IVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk category: IVDR Class B
Manufacturer: Hangzhou Laihe Biotech Co., Ltd.

Device family identification

Device name: Dengue IgG/IgM Test Kit (Colloidal Gold)
Basic UDI-DI: 697241261IDE-A402EJ
Device model: IDE-A402-01; IDE-A402-05; IDE-A402-20; IDE-A402-25; IDE-A402-40
Issuing agency: GS1
Version date: Jun 4, 2026

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk category: IVDR Class B
Status: On the market

ReagentProfessional testingAnimal tissues / cells

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

References

5 references

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
LYHER	`IDE-A402-25`	`06972412613991`	1	On the market
LYHER	`IDE-A402-40`	`06972412615872`	1	On the market
LYHER	`IDE-A402-05`	`06972412618514`	1	On the market
LYHER	`IDE-A402-20`	`06972412618798`	1	On the market
LYHER	`IDE-A402-01`	`06972412618484`	1	On the market