Data from EUDAMED, last updated Jun 11, 2026

High-density Lipoprotein Cholesterol (HDL-C) Test Kit (Direct-Selective Suppression)

B-06971674860556

1 reference

IVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk category: IVDD — General
Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.

Device family identification

Device name: High-density Lipoprotein Cholesterol (HDL-C) Test Kit (Direct-Selective Suppression)
Basic UDI-DI: B-06971674860556
Device model: R1:48mL×2 R2:16mL×2(713)
Issuing agency: EUDAMED
Version date: May 15, 2026

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

ReagentProfessional testing

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
High-density Lipoprotein Cholesterol (HDL-C) Test Kit (Direct-Selective Suppression)	`R1:48mL×2 R2:16mL×2(713)`	`06971674860556`	1	On the market