D-Dimer Chemiluminescent Immunoassay Kit

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref IM4407159 EMDN W0103020503

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	NumberB-IM4407159K7 Basic UDI-DI	Date22 May 2022Registered	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Withdrawn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

Device Name: D-Dimer Chemiluminescent Immunoassay Kit
Model / Reference: IM4407159

Primary DI / UDI-DI: D-IM4407159K7
Basic UDI-DI: B-IM4407159K7
EMDN Code: W0103020503 D-dimer

Device Class: Class IVD General
Market of Registration: Spain

Manufacturer details

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

Other devices from Maccura Biotechnology Co., Ltd.

Magnesium Assay Kit (Xylidyl Blue Method)

Class B
Automatic Hematology Analyzer F-DC Diluent

Class A
γ-Glutamyltransferase Assay Kit (Glycylglycine Cyanide Anilide Method)

Class B
Lactic Acid Assay Kit (Lactate Oxidase Method)

Class B
Cholinesterase Assay Kit (Butyrylthiocholine Substrate Method)

Class B
Lactate Dehydrogenase Assay Kit (Lactate Substrate Method)

Class B

See all devices from Maccura Biotechnology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records

Human Tissues
Animal Tissues
Reagent
Professional Testing

Other properties (6)

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

Sources (1)

EUDAMED c300dc49-cec6-4457-a967-d8b9bdca7fb4 61 fields · synced 22 Oct 2026