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Apolipoprotein E Reagent Kit (Immunoturbidimetric Assay)

EUDAMED

Class IVD General (EU MDR)

Ref 3011549Model R1: 1x30mL, R2: 1x10mLRef 3012970Ref 3021589Model R1: 1x30mL, R2: 1x10mL，

by Dirui Industrial Co., Ltd

Identity

Trade Name
Apolipoprotein E Reagent Kit (Immunoturbidimetric Assay) EUDAMED
Device Name
Apolipoprotein E Reagent Kit (Immunoturbidimetric Assay) EUDAMED
Model / Reference
R1: 1x30mL, R2: 1x10mL EUDAMED
3011549 EUDAMED
3012970 EUDAMED
R1: 1x30mL, R2: 1x10mL， EUDAMED
3021589 EUDAMED

Identifiers

Primary DI / UDI-DI
06942202247163 EUDAMED
06942202261206 EUDAMED
06925794593733 EUDAMED
Basic UDI-DI
B-06942202247163 EUDAMED
B-06942202261206 EUDAMED
B-06925794593733 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

No

EUDAMED

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 E 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 bc8e8448-030f-491a-9ca6-a0264bcc0f81 61 fields · synced Jul 29, 2026
  • EUDAMED c5c8ea98-e5dd-4ae5-a9dd-2e02e62ab068 61 fields · synced May 17, 2026
  • EUDAMED a1dbfd7a-da39-425c-973d-3f1af6de5459 61 fields · synced Jul 29, 2026