Hantavirus Rapid Test - WB

EUDAMED

Class IVD General (EU MDR)

Ref HV-4012

by Safecare Biotech (hangzhou) Co., Ltd.

Identity

Trade Name: Hantavirus Rapid Test(WB/S/P) EUDAMED
Device Name: Hantavirus Rapid Test(WB/S/P) EUDAMED
Model / Reference: HV-4012 EUDAMED

Identifiers

Primary DI / UDI-DI: D-697424646HV001H4K2 EUDAMED
Basic UDI-DI: B-697424646HV001H4K2 EUDAMED
EMDN Code: W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Models / Variants: WB EUDAMED
S EUDAMED
P 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

Hantavirus Rapid Test - WB by Safecare Biotech (Hangzhou) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — 3 models — 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-697424646HV001H4K2	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 cfa53043-2939-4ea5-b760-80f8279b5d72 61 fields · synced Oct 6, 2026