Homocysteine (Hcy)

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref ECH0101351, ECH0192351, ECH0195351

EMDN W01021307

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-ECH010135153 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: Homocysteine (Hcy)
Homocysteine (Hcy) Control
Model / Reference: ECH0101351, ECH0192351, ECH0195351

Primary DI / UDI-DI: D-ECH010135153, D-ECH01923518D, D-ECH019535192
Basic UDI-DI: B-ECH010135153, B-ECH01923518D, B-ECH019535192
EMDN Code: W01021307, W0101050299

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
Microbial Substances YesEUDAMEDNoEUDAMED
Reagent YesEUDAMEDNoEUDAMED
Professional Testing

Other properties (6)

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

Sources (3)

EUDAMED 88492a3d-1b5b-4ab6-be26-98103405f083 61 fields · synced 22 Oct 2026
EUDAMED D-ECH01923518D|B-ECH01923518D 61 fields · synced 18 May 2026
EUDAMED D-ECH019535192|B-ECH019535192 61 fields · synced 19 May 2026