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β2-Microglobulin Test Kit (Latex Immunoturbidimetric Method)

EUDAMED

Class IVD General (EU MDR)

Ref /

by Shanghai Kehua Bio-engineering Co., Ltd.

Identity

Device Name
β2-Microglobulin Test Kit (Latex Immunoturbidimetric Method) EUDAMED
Model / Reference
/ EUDAMED

Identifiers

Primary DI / UDI-DI
D-11K7Y EUDAMED
Basic UDI-DI
B-11K7Y EUDAMED
EMDN Code
W0102039002 BETA2-MICROGLOBULIN EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Belgium EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

Yes

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

β2-Microglobulin Test Kit (Latex Immunoturbidimetric Method) by Shanghai Kehua Bio-engineering 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
Shanghai Kehua Bio-engineering Co., Ltd.
EUDAMED SRN
CN-MF-000026756
Authorised Representative
QbD RepS BV BE-AR-000000040

Sources (1)

  • EUDAMED 02308ead-5a49-4bba-b1ab-678752388fe9 61 fields · synced Jul 11, 2026