Glucose Reagent Kit（Hexokinase Method）

EUDAMED

Class IVD General (EU MDR)

Ref "REF: U83885040M U83889060M, U83822060M U83885020M"

by URIT Medical Electronic Co., Ltd.

Identity

Device Name: Glucose Reagent Kit（Hexokinase Method） EUDAMED
Model / Reference: "REF: U83885040M U83889060M, U83822060M U83885020M" EUDAMED

Identifiers

Primary DI / UDI-DI: D-6-131FB EUDAMED
Basic UDI-DI: B-6-131FB EUDAMED
EMDN Code: W01010213 GLUCOSE EUDAMED

Classification

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

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

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

Glucose Reagent Kit（Hexokinase Method） by URIT Medical Electronic Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

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-6-131FB	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 c9bba79b-347d-41e4-98eb-37de292150b3-1 61 fields · synced Oct 7, 2026
EUDAMED c9bba79b-347d-41e4-98eb-37de292150b3-2 61 fields · synced Jul 9, 2026