Folate Chemiluminescent Binding Assay Kit

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref IM4403211Model IM4402211 IM4403211 EIM4406211 EIM4407211 EMDN W0102070103

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number69506174IM440211D3 Basic UDI-DI	Date30 Apr 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Withdrawn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 25 Oct 2026

Device Name: Folate Chemiluminescent Binding Assay Kit
Model / Reference: IM4402211 IM4403211 EIM4406211 EIM4407211, IM4403211

Primary DI / UDI-DI: 06950617401674
Basic UDI-DI: 69506174IM440211D3
Direct Marketing DI: 06950617401674
EMDN Code: W0102070103 Folate

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
Reagent
Professional Testing

Other properties (7)

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

Sources (1)

EUDAMED 67f1de1b-a56d-49a7-b9c5-1a905c7c6c96 61 fields · synced 25 Oct 2026