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Β2mg Fia

EUDAMED

Class IVD General (EU MDR)

Ref β2mg-W23F3

by Assure Tech. (Hangzhou) Co., Ltd.

Identity

Trade Name: β2MG FIA EUDAMED
Device Name: β2MG FIA EUDAMED
Model / Reference: β2mg-W23F3 EUDAMED

Identifiers

Primary DI / UDI-DI: 06952804803445 EUDAMED
Basic UDI-DI: B-06952804803445 EUDAMED
EMDN Code: W0102039002 BETA2-MICROGLOBULIN EUDAMED

Classification

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

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

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

Β2mg Fia by Assure Tech. (hangzhou) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

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

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Beta2-microglobulin urine — Diagam S.A. · IVD General
BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class II
Beta2-microglobulin urine — Diagam S.A. · IVD General
Beta2-microglobulin — Diagam S.A. · IVD General
BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class II
BETA2-Microglobulin (BETA2-MG) Test — Beijing Jinwofu Bioengineering Technology Co., Ltd. · IVD General

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
EUDAMED SRN: CN-MF-000002170
Authorised Representative: Lotus NL B.V. NL-AR-000000121

Sources (1)

EUDAMED 99cd5a72-c82a-487b-b7a1-49194778bf1b 61 fields · synced Jun 20, 2026