Insulin Chemiluminescent Immunoassay Kit

by Maccura Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref IM4402401

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-IM4402401HL 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Withdrawn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

Device Name: Insulin Chemiluminescent Immunoassay Kit
Model / Reference: IM4402401

Primary DI / UDI-DI: D-IM4402401HL
Basic UDI-DI: B-IM4402401HL
EMDN Code: W0102060103 Insulin

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

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Properties

Show properties

Animal Tissues
Microbial Substances
Reagent
Professional Testing

Other properties (6)

Sterile: No
Human Tissues: No
Self Testing: No
Near-Patient Testing: No
Companion Diagnostics: No
Surgical Instrument: No