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Β2-Microglobulin Reagent Kit（latex Enhanced Immunoturbidimetric Assay）

EUDAMED

Class IVD General (EU MDR)

Ref 3001084Model Calibration sample: 1×1mLRef 3024318Model Type B：5×0.5mL（5levels）

by Dirui Industrial Co., Ltd

Identity

Trade Name
β2-MICROGLOBULIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY） EUDAMED
β2-Microglobulin Calibrator EUDAMED
Device Name
β2-MICROGLOBULIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY） EUDAMED
β2-Microglobulin Calibrator EUDAMED
Model / Reference
Calibration sample: 1×1mL EUDAMED
3001084 EUDAMED
Type B：5×0.5mL（5levels） EUDAMED
3024318 EUDAMED

Identifiers

Primary DI / UDI-DI
06942202261589 EUDAMED
06942202223273 EUDAMED
Basic UDI-DI
B-06942202261589 EUDAMED
B-06942202223273 EUDAMED
EMDN Code
W0102019099 SPECIFIC PROTEINS - OTHER EUDAMED
W0102152299 STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Austria EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

Yes

EUDAMED

Animal Tissues

No

EUDAMEDEUDAMED

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

Β2-Microglobulin Reagent Kit（latex Enhanced Immunoturbidimetric Assay） by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Dirui Industrial Co., Ltd
EUDAMED SRN
CN-MF-000001891
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (2)

  • EUDAMED 0581336f-f29a-40ee-b55c-051157e674bf 61 fields · synced Aug 2, 2026
  • EUDAMED 7a904346-5599-42a9-8e5b-16c8a9384ed2 61 fields · synced Jul 28, 2026