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Apolipoprotein C2 Reagent Kit (Immunoturbidimetric Assay)

EUDAMED

Class IVD General (EU MDR)

Ref 3011774Model R1: 1x45mL, R2: 1x15mL, Calibration sample: 1x1mL, Control: 2x1mLRef 3011912Model R1: 1x45mL, R2: 1x15mLRef 3021643

by Dirui Industrial Co., Ltd

Identity

Trade Name
Apolipoprotein C2 Reagent Kit (Immunoturbidimetric Assay) EUDAMED
Device Name
Apolipoprotein C2 Reagent Kit (Immunoturbidimetric Assay) EUDAMED
Model / Reference
R1: 1x45mL, R2: 1x15mL, Calibration sample: 1x1mL, Control: 2x1mL EUDAMED
3011774 EUDAMED
R1: 1x45mL, R2: 1x15mL EUDAMED
3011912 EUDAMED
3021643 EUDAMED

Identifiers

Primary DI / UDI-DI
06942202247149 EUDAMED
06942202247156 EUDAMED
06925794593696 EUDAMED
Basic UDI-DI
B-06942202247149 EUDAMED
B-06942202247156 EUDAMED
B-06925794593696 EUDAMED
EMDN Code
W0102010499 LIPOPROTEINS - OTHER EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Austria EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

Yes

EUDAMEDEUDAMED

Animal Tissues

Yes

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

Apolipoprotein C2 Reagent Kit (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 (3)

  • EUDAMED 80b4a5d0-29c3-4195-b2b2-444da0d584c9 61 fields · synced Jul 16, 2026
  • EUDAMED 52e1ae9b-59a6-424f-aeaa-71ae395f127b 61 fields · synced May 17, 2026
  • EUDAMED 11b34543-3f04-4ea4-91d7-3b9384f93530 61 fields · synced Jul 16, 2026