HCG Calibrators

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref EIM4283001

EMDN W0102152202

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-EIM4283001H5 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: HCG Calibrators
Model / Reference: EIM4283001

Primary DI / UDI-DI: D-EIM4283001H5
Basic UDI-DI: B-EIM4283001H5
EMDN Code: W0102152202 Hormone standards and calibrators

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 b7d04b85-67b6-4e5f-981d-0b4d3b6a381f 61 fields · synced 24 Oct 2026