HE4 Control

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref EIM4492115

EMDN W0102152005

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-EIM4492115JK 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: HE4 Control
Model / Reference: EIM4492115

Primary DI / UDI-DI: D-EIM4492115JK
Basic UDI-DI: B-EIM4492115JK
EMDN Code: W0102152005 Tumour marker controls

Device Class: Class IVD General
Market of Registration: Spain

Manufacturer details

EUDAMED SRN: CN-MF-000014618
Authorised representative: Humiss International B.V. NL-AR-000001490

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Properties & raw data

Show properties, registry sources and raw records

Animal Tissues
Microbial Substances
Professional Testing

Other properties (7)

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

Sources (1)

EUDAMED 038de5bf-6d4a-4bf1-95b0-8015439a81db 61 fields · synced 22 Oct 2026