E2 (Clia)

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref IM4403209

EMDN W0102050103

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-IM4403209HZ 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: E2 (Clia)
Model / Reference: IM4403209

Primary DI / UDI-DI: D-IM4403209HZ
Basic UDI-DI: B-IM4403209HZ
EMDN Code: W0102050103 Estradiol

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
Reagent
Professional Testing

Other properties (7)

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

Sources (1)

EUDAMED a39d3590-0639-4f53-a19d-c3dc5b598a42 61 fields · synced 22 Oct 2026