Malaria P.v./Pan Rapid Test (Whole Blood)

EUDAMED

Class IVD General (EU MDR)

Ref MAL-4022c

by Safecare Biotech (hangzhou) Co., Ltd.

Identity

Trade Name: Malaria P.v./Pan Rapid Test (Whole Blood) EUDAMED
Device Name: Malaria P.v./Pan Rapid Test (Whole Blood) EUDAMED
Model / Reference: MAL-4022c EUDAMED

Identifiers

Primary DI / UDI-DI: D-697424646MAL005GVVC EUDAMED
Basic UDI-DI: B-697424646MAL005GVVC EUDAMED
EMDN Code: W0105090401 PLASMODIUM (MALARIA) - RT & POC EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Market of Registration: Germany EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

Malaria P.v./Pan Rapid Test (Whole Blood) by Safecare Biotech (Hangzhou) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDD	B-697424646MAL005GVVC	Class IVD General	Active

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Manufacturer

Manufacturer: Safecare Biotech (hangzhou) Co., Ltd.
EUDAMED SRN: CN-MF-000019109
Authorised Representative: UnicareQ GmbH DE-AR-000051497

Sources (1)

EUDAMED c1054aae-5cde-4909-a131-f0313fdd3fc2 61 fields · synced Aug 3, 2026