HSV-1/2 IgM Control

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref EIM4297332

EMDN W0105080899

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-EIM4297332K6 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 24 Oct 2026

Device Name: HSV-1/2 IgM Control
Model / Reference: EIM4297332

Primary DI / UDI-DI: D-EIM4297332K6
Basic UDI-DI: B-EIM4297332K6
EMDN Code: W0105080899 Controls - inf. immunology - other

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
Professional Testing

Other properties (8)

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

Sources (1)

EUDAMED 46812743-4a24-4873-ae85-f0c8c7a7fab7 61 fields · synced 24 Oct 2026