Down Syndrome Markers Control

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref IM4295507

EMDN W01021521

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-IM4295507M3 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: Down Syndrome Markers Control
Model / Reference: IM4295507

Primary DI / UDI-DI: D-IM4295507M3
Basic UDI-DI: B-IM4295507M3
EMDN Code: W01021521 Multicomponent immunochemistry controls

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

Human Tissues
Animal Tissues
Professional Testing

Other properties (7)

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

Sources (1)

EUDAMED d947feab-4657-4987-a23c-2bcbe5884c9c 61 fields · synced 24 Oct 2026