Rapid Test for IgM Antibody to Hepatitis A Virus (Colloidal Gold Device)

EUDAMED

Class IVD General (EU MDR)

Ref WJ-1010 Ref WJ-1050

by Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

Identity

Device Name: Rapid Test for IgM Antibody to Hepatitis A Virus (Colloidal Gold Device) EUDAMED
Model / Reference: WJ-1010 EUDAMED
WJ-1050 EUDAMED

Identifiers

Primary DI / UDI-DI: 06970301452553 EUDAMED
06970301452690 EUDAMED
Basic UDI-DI: B-06970301452553 EUDAMED
B-06970301452690 EUDAMED
EMDN Code: W0105020104 HAV ANTIBODY IGM EUDAMED

Classification

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

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

Yes

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

Rapid Test for IgM Antibody to Hepatitis A Virus (Colloidal Gold Device) by Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. — Class IVD General — IVDD…

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-06970301452553	Class IVD General	Active

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Manufacturer

Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
EUDAMED SRN: CN-MF-000040626
Authorised Representative: QbD RepS BV BE-AR-000000040

Sources (2)

EUDAMED 503a4a71-34c6-4a3c-b822-31f18197545c 61 fields · synced Oct 6, 2026
EUDAMED 46c1d702-a7a8-4bbe-b5a7-7d36d9694524 61 fields · synced May 19, 2026