Mycoplasma Pneumoniae IgM Antibody Chemiluminescent Immunoassay Kit

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref IM4407041

EMDN W0105010899

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	NumberB-IM4407041JF Basic UDI-DI	Date22 May 2022Registered	StatusActive

Coverage

1 jurisdiction

Active
Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name: Mycoplasma Pneumoniae IgM Antibody Chemiluminescent Immunoassay Kit
Model / Reference: IM4407041

Primary DI / UDI-DI: D-IM4407041JF
Basic UDI-DI: B-IM4407041JF
EMDN Code: W0105010899 Mycoplasma / ureaplasma reagents - other

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 & raw data

Show properties, registry sources and raw records

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

Sources (1)

EUDAMED 1a13f17e-0b45-4263-8474-2d0e5bb44546 61 fields · synced 22 Oct 2026