Creatine Kinase Isoenzymes (CK-MB) Test Kit (Immunofluorescence Method)

EUDAMED

Class IVD General (EU MDR)

Ref W-IF2-CK-MB-40Model 40 tests/kit

by Wuhan Easydiagnosis Biomedicine Co., Ltd.

Identity

Device Name: Creatine Kinase Isoenzymes (CK-MB) Test Kit (Immunofluorescence Method) EUDAMED
Model / Reference: 40 tests/kit EUDAMED
W-IF2-CK-MB-40 EUDAMED

Identifiers

Primary DI / UDI-DI: 06978896415946 EUDAMED
Basic UDI-DI: B-06978896415946 EUDAMED
EMDN Code: W0102160701 CREATINE KINASE - MB MASS - RT & POC EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Market of Registration: Romania EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

Creatine Kinase Isoenzymes (CK-MB) Test Kit (Immunofluorescence Method) by Wuhan Easydiagnosis Biomedicine Co., Ltd. — Class IVD General — IVDD — listed in…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDD	B-06978896415946	Class IVD General	Active

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Manufacturer

Manufacturer: Wuhan Easydiagnosis Biomedicine Co., Ltd.
EUDAMED SRN: CN-MF-000019908
Authorised Representative: CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (1)

EUDAMED db4b3b59-80ae-4fb2-ae34-0f3c7fa9d5f4 61 fields · synced Oct 7, 2026