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Beta 2 Microglobulin (β2-MG) Test Kit (Immunofluorescence Method)

EUDAMED

Class IVD General (EU MDR)

Ref W-IF2-β2-MG-40Model 40 tests/kit

by Wuhan Easydiagnosis Biomedicine Co., Ltd.

Identity

Device Name
Beta 2 Microglobulin (β2-MG) Test Kit (Immunofluorescence Method) EUDAMED
Model / Reference
40 tests/kit EUDAMED
W-IF2-β2-MG-40 EUDAMED

Identifiers

Primary DI / UDI-DI
06978896416004 EUDAMED
Basic UDI-DI
B-06978896416004 EUDAMED
EMDN Code
W0102039002 BETA2-MICROGLOBULIN EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Romania EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Category: Beta-2-microglobulin IVD, reagent

Beta 2 Microglobulin (β2-MG) Test Kit (Immunofluorescence Method) by Wuhan Easydiagnosis Biomedicine Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED

Similar devices

Also classified as Beta-2-microglobulin IVD, reagent.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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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 1f1af82e-e0a6-4be0-b9c3-9a0852999283 61 fields · synced Jun 18, 2026