HSV-2 IgG

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref EIM4202328

EMDN W0105040309

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-EIM4202328F9 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 23 Oct 2026

Device Name: HSV-2 IgG
Model / Reference: EIM4202328

Primary DI / UDI-DI: D-EIM4202328F9
Basic UDI-DI: B-EIM4202328F9
EMDN Code: W0105040309 Hsv 2 igg

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 c96a2312-a8d1-4f94-a246-52a809746b12 61 fields · synced 23 Oct 2026