Chlamydia Pneumoniae IgG Antibody Chemiluminescent Immunoassay Kit

by Maccura Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref EIM4410015, EIM4415015, EIM4414015Model EIM4410015 EIM4411015 EIM4414015 EIM4415015

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number69506174IM441015D8 Basic UDI-DI	Date4 May 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Withdrawn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

Device Name: Chlamydia Pneumoniae IgG Antibody Chemiluminescent Immunoassay Kit
Model / Reference: EIM4410015 EIM4411015 EIM4414015 EIM4415015, EIM4410015, EIM4415015, EIM4414015

Primary DI / UDI-DI: 06950617409755, 06950617418214, 06950617418207
Basic UDI-DI: 69506174IM441015D8
Direct Marketing DI: 06950617409755
06950617418214
06950617418207
EMDN Code: W0105010115 Chlamydia pneumoniae antibody igg

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

Human Tissues
Animal Tissues
Microbial Substances
Reagent
Professional Testing

Other properties (6)

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