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Beta-2-microglobulin Kit (Microfluidic Fluorescent Immunoassay)

EUDAMED

Class IVD General (EU MDR)

Ref /

by Hunan Kangxin Biotechnology Co., Ltd.

Identity

Device Name
Beta-2-microglobulin Kit (Microfluidic Fluorescent Immunoassay) EUDAMED
Model / Reference
/ EUDAMED

Identifiers

Primary DI / UDI-DI
D-TD-HNKX-CED-594N EUDAMED
Basic UDI-DI
B-TD-HNKX-CED-594N EUDAMED
EMDN Code
W0102039002 BETA2-MICROGLOBULIN EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Spain EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

Yes

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 Kit (Microfluidic Fluorescent Immunoassay) by Hunan Kangxin Biotechnology 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
Hunan Kangxin Biotechnology Co., Ltd.
EUDAMED SRN
CN-MF-000020121
Authorised Representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (1)

  • EUDAMED 095c2ef0-1a3d-4176-95e8-a1a87ebc4237 61 fields · synced Jul 17, 2026