2019-nCoV IgG/gM Antibody Rapid Test Kit

by Beijing Diagreat Biotechnologies Co., Ltd. EUDAMED

Active European Union

Ref P11803Model 25 tests/box

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number697518250P118036Q Basic UDI-DI	Date28 May 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference: 25 tests/box, P11803

Primary DI / UDI-DI: 06942293581757
Basic UDI-DI: 697518250P118036Q
Direct Marketing DI: 06942293581757
EMDN Code: W0105041102 Coronavirus antibodies - total

Device Class: Class B
Market of Registration: Italy

Manufacturer details

EUDAMED SRN: CN-MF-000019511
Authorised representative: MedNet EC-REP GmbH DE-AR-000000002

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Properties

Reagent
Professional Testing
New Device

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