β2-Microglobulin (β2-MG) testing kit (latex immunoturbidimetric method)

EUDAMED

Class IVD General (EU MDR)

Ref "REF: U85782020M, U85781040M, U85789060M, U85785020M, U85720060M"

by URIT Medical Electronic Co., Ltd.

Identity

Device Name: β2-Microglobulin (β2-MG) testing kit (latex immunoturbidimetric method) EUDAMED
Model / Reference: "REF: U85782020M, U85781040M, U85789060M, U85785020M, U85720060M" EUDAMED

Identifiers

Primary DI / UDI-DI: D-6-46AJ EUDAMED
Basic UDI-DI: B-6-46AJ EUDAMED
EMDN Code: W0102019099 SPECIFIC PROTEINS - OTHER EUDAMED

Classification

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

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

Yes

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

β2-Microglobulin (β2-MG) testing kit (latex immunoturbidimetric method) by URIT Medical Electronic Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDD	B-6-46AJ	Class IVD General	Active

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Manufacturer

Manufacturer: URIT Medical Electronic Co., Ltd.
EUDAMED SRN: CN-MF-000011840
Authorised Representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (2)

EUDAMED 7a80c31e-4834-48d5-82f4-e6d50afc6751-1 61 fields · synced Jul 27, 2026
EUDAMED 7a80c31e-4834-48d5-82f4-e6d50afc6751-2 61 fields · synced Jul 27, 2026