Control for Automatic Hematology Analyzer (5-part)

EUDAMED

Class IVD General (EU MDR)

Ref 3001375Model Level 3: 2.5 mlRef 3001374Model Level 1: 2.5 mlRef 3001373Model Level 2: 2.5 ml

by Dirui Industrial Co., Ltd

Identity

Trade Name: Control for Automatic Hematology Analyzer (5-part) EUDAMED
Device Name: Control for Automatic Hematology Analyzer (5-part) EUDAMED
Model / Reference: Level 3: 2.5 ml EUDAMED
3001375 EUDAMED
Level 1: 2.5 ml EUDAMED
3001374 EUDAMED
Level 2: 2.5 ml EUDAMED
3001373 EUDAMED

Identifiers

Primary DI / UDI-DI: 06925794504319 EUDAMED
06925794504296 EUDAMED
06925794504302 EUDAMED
Basic UDI-DI: B-06925794504319 EUDAMED
B-06925794504296 EUDAMED
B-06925794504302 EUDAMED
EMDN Code: W0103010599 HAEMATOLOGY CONTROLS - OTHER EUDAMED

Classification

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

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

Control for Automatic Hematology Analyzer (5-part) by Dirui Industrial 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-06925794504319	Class IVD General	Active

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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 (3)

EUDAMED 819ee89c-9ad9-4040-816d-b8f23a7c8d75 61 fields · synced Sep 30, 2026
EUDAMED 98761ee1-5789-462c-8a7c-7eb06a6e2d47 61 fields · synced May 17, 2026
EUDAMED 8e4eb561-2f29-45e8-a173-93e486d49f3c 61 fields · synced May 17, 2026