HEV IgG Chemiluminescent Immunoassay Kit

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref EIM4492017Model IM4402017 IM4403017 IM4406017 IM4407017 EIM4492017 EMDN W0105020504

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number69506174IM440017D5 Basic UDI-DI	Date16 Jun 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name: HEV IgG Chemiluminescent Immunoassay Kit
Model / Reference: IM4402017 IM4403017 IM4406017 IM4407017 EIM4492017, EIM4492017

Primary DI / UDI-DI: 06950617420255
Basic UDI-DI: 69506174IM440017D5
Direct Marketing DI: 06950617420255
EMDN Code: W0105020504 Hev antibody igg

Device Class: Class B
Market of Registration: Spain

Manufacturer details

EUDAMED SRN: CN-MF-000014618
Authorised representative: CMC Medical Devices & Drugs SL ES-AR-000000293

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Properties & raw data

Show properties, registry sources and raw records

Human Tissues
Animal Tissues
Microbial Substances
Reagent
Professional Testing

Other properties (6)

Sterile: No
Self Testing: No
Near-Patient Testing: No
Companion Diagnostics: No
Surgical Instrument: No
New Device: No

Sources (1)

EUDAMED 06950617420255|69506174IM440017D5 61 fields · synced 24 Oct 2026