Chemiluminescence Analyzer Reaction Cuvettes

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref EIM4401465Model 3500 Tests, 24 kits/Box EMDN W0503010203

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number69506174IM440465E4 Basic UDI-DI	Date14 Feb 2025Registered	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Withdrawn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 22 Oct 2026

Model / Reference: 3500 Tests, 24 kits/Box, EIM4401465

Primary DI / UDI-DI: 06950617423454
Basic UDI-DI: 69506174IM440465E4
Direct Marketing DI: 06950617423454
EMDN Code: W0503010203 Samples analyses, plastic cuvettes

Device Class: Class A
Market of Registration: Türkiye

Manufacturer details

EUDAMED SRN: CN-MF-000014618
Authorised representative: Humiss International B.V. NL-AR-000001490

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Properties & raw data

Show properties, registry sources and raw records

Reagent
Professional Testing

Other properties (9)

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

Sources (1)

EUDAMED 6289c0da-4c5b-49e5-8cbf-6d973397e06c 61 fields · synced 22 Oct 2026