Hepatitis A Virus IgM Antibody Rapid Test Cassette (Colloidal Gold Method)

by Beijing Applied Biological Technologies Co., Ltd. EUDAMED

Active European Union

Ref IH007

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-06974323018292 Basic UDI-DI	Date18 May 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name: Hepatitis A Virus IgM Antibody Rapid Test Cassette (Colloidal Gold Method)
Model / Reference: IH007

Primary DI / UDI-DI: 06974323018292
Basic UDI-DI: B-06974323018292
EMDN Code: W0105020104 Hav antibody igm

Device Class: Class IVD General
Market of Registration: Germany

Manufacturer details

EUDAMED SRN: CN-MF-000012338
Authorised representative: Luxus Lebenswelt GmbH DE-AR-000005110

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Properties

Show properties

Reagent
Professional Testing

Other properties (8)

Sterile: No
Human Tissues: No
Animal Tissues: No
Microbial Substances: No
Self Testing: No
Near-Patient Testing: No
Companion Diagnostics: No
Surgical Instrument: No