Anti-Müllerian Hormone (AMH) Chemiluminescent Immunoassay Kit

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref IM4407208

EMDN W0102050215

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-IM4407208JT 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: Anti-Müllerian Hormone (AMH) Chemiluminescent Immunoassay Kit
Model / Reference: IM4407208

Primary DI / UDI-DI: D-IM4407208JT
Basic UDI-DI: B-IM4407208JT
EMDN Code: W0102050215 Anti-mullerian hormone

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
Microbial Substances
Reagent
Professional Testing

Other properties (6)

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

Sources (1)

EUDAMED deaecb36-98c4-4304-8eee-ec9464b80be1 61 fields · synced 22 Oct 2026