Monkeypox virus (MPXV) Antigen Rapid Test Cassette

by Beijing Applied Biological Technologies Co., Ltd. EUDAMED

Active European Union

Ref G10P20-X1

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-06974323017028 Basic UDI-DI	Date15 Apr 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Withdrawn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: Monkeypox virus (MPXV) Antigen Rapid Test Cassette
Model / Reference: G10P20-X1

Primary DI / UDI-DI: 06974323017028
Basic UDI-DI: B-06974323017028
EMDN Code: W0105099008 Monkeypox virus / mpox rt & poc

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