SARS-CoV-2 Antigen (CLIA)

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref EIM4403017

EMDN W0105040605

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-EIM4403017FN Basic UDI-DI	Date22 May 2022Registered	StatusActive

Coverage

1 jurisdiction

Expiring (legacy directive)
Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name: SARS-CoV-2 Antigen (CLIA)
Model / Reference: EIM4403017

Primary DI / UDI-DI: D-EIM4403017FN
Basic UDI-DI: B-EIM4403017FN
EMDN Code: W0105040605 Respiratory syncytial virus (rsv)

Device Class: Class IVD General
Market of Registration: Germany

Manufacturer details

EUDAMED SRN: CN-MF-000014618
Authorised representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties & raw data

Show properties, registry sources and raw records

Animal Tissues
Microbial Substances
Reagent
Professional Testing

Other properties (6)

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

Sources (1)

EUDAMED 724ecb3c-8f0f-4303-b77b-a6cd53ec9071 61 fields · synced 22 Oct 2026