Data from EUDAMED, last updated Jun 11, 2026

Malaria Pan Rapid Test (Whole Blood)

B-697424646MAL002GPUH

1 reference

IVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk category: IVDD — General
Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.

Device family identification

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.

Data from EUDAMED, last updated Jun 11, 2026

B-697424646MAL002GPUH

1 reference

IVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk category: IVDD — General
Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.

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.

1 reference

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
Malaria Pan Rapid Test (Whole Blood)	`MAL-4011c/MAL-4012c`	`D-697424646MAL002GPUH`	1	On the market