W0105010116

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref EIM4415016Model EIM4410016 EIM4411016 EIM4414016 EIM4415016

EMDN W0105010116

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number69506174IM441016DA Basic UDI-DI	Date4 May 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name: W0105010116
Model / Reference: EIM4410016 EIM4411016 EIM4414016 EIM4415016, EIM4415016

Primary DI / UDI-DI: 06950617418283
Basic UDI-DI: 69506174IM441016DA
Direct Marketing DI: 06950617418283
EMDN Code: W0105010116 Chlamydia pneumoniae antibody igm

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

Animal Tissues
Microbial Substances
Reagent
Professional Testing

Other properties (7)

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

Sources (1)

EUDAMED 42d22402-ae32-4dc1-8822-84ca4c1a21e3 61 fields · synced 24 Oct 2026