Folate Chemiluminescent Binding Assay Kit

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref IM4402211 EMDN W0102070103

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-IM4402211HD Basic UDI-DI	Date22 May 2022Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name: Folate Chemiluminescent Binding Assay Kit
Model / Reference: IM4402211

Primary DI / UDI-DI: D-IM4402211HD
Basic UDI-DI: B-IM4402211HD
EMDN Code: W0102070103 Folate

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 573df718-8791-4fc0-a518-62d7ecd1c6e5 61 fields · synced 22 Oct 2026