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Microalbumin Reagent Kit（immunoturbidimetric Assay）

EUDAMED

Class IVD General (EU MDR)

Ref 3001071Model Calibration sample: 5×0.5mLRef 3004703Model R1: 1x40mL, R2: 1x10mL, Calibration sample: 5x0.5mLRef 3021563Model R1: 1x40mL, R2: 1x10mL, Calibration sample: 5x0.5mL, Control: 2x1mLRef 3023245Ref 3021624Model R1: 1x40mL, R2: 1x10mLRef 3021173Ref 3004705Model R1: 1x40mL, R2: 1x10mL,Control : 2x1mLRef 3016553Model R1: 1x40mL, R2: 1x10mL, Calibration sample: 5x0.5mL,Control: 2x1mL,

by Dirui Industrial Co., Ltd

Identity

Trade Name
MICROALBUMIN REAGENT KIT（IMMUNOTURBIDIMETRIC ASSAY） EUDAMED
Device Name
MICROALBUMIN REAGENT KIT（IMMUNOTURBIDIMETRIC ASSAY） EUDAMED
Model / Reference
Calibration sample: 5×0.5mL EUDAMED
3001071 EUDAMED
R1: 1x40mL, R2: 1x10mL, Calibration sample: 5x0.5mL EUDAMED
3004703 EUDAMED
R1: 1x40mL, R2: 1x10mL, Calibration sample: 5x0.5mL, Control: 2x1mL EUDAMED
3021563 EUDAMED
3023245 EUDAMED
R1: 1x40mL, R2: 1x10mL EUDAMED
3021624 EUDAMED
3021173 EUDAMED
R1: 1x40mL, R2: 1x10mL,Control : 2x1mL EUDAMED
3004705 EUDAMED
R1: 1x40mL, R2: 1x10mL, Calibration sample: 5x0.5mL,Control: 2x1mL, EUDAMED
3016553 EUDAMED

Identifiers

Primary DI / UDI-DI
06942202261602 EUDAMED
06942202259685 EUDAMED
06925794592996 EUDAMED
06942202213380 EUDAMED
06925794592989 EUDAMED
06942202259692 EUDAMED
06942202259654 EUDAMED
06942202259661 EUDAMED
Basic UDI-DI
B-06942202261602 EUDAMED
B-06942202259685 EUDAMED
B-06925794592996 EUDAMED
B-06942202213380 EUDAMED
B-06925794592989 EUDAMED
B-06942202259692 EUDAMED
B-06942202259654 EUDAMED
B-06942202259661 EUDAMED
EMDN Code
W0102019099 SPECIFIC PROTEINS - 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

No

EUDAMEDEUDAMED

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

Microalbumin Reagent Kit（immunoturbidimetric Assay） 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

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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 (8)

  • EUDAMED db943ff6-1875-4543-af84-bfa59fd983f0 61 fields · synced Aug 4, 2026
  • EUDAMED a3cf34cf-c42c-42b6-9083-1914e567fce4 61 fields · synced May 16, 2026
  • EUDAMED 0f0b03f1-9273-4c82-b73f-8df05c5c2af9 61 fields · synced May 17, 2026
  • EUDAMED 36280084-1237-401c-80e3-dc6aff372097 61 fields · synced May 17, 2026
  • EUDAMED 20978f1a-d44a-49ea-a1d8-ee880f19b5ff 61 fields · synced May 17, 2026
  • EUDAMED d761dbcf-4c0b-4496-9ce4-b2c00c9deece 61 fields · synced May 17, 2026
  • EUDAMED 6cf178af-6e86-4fab-9001-9210717a1fc1 61 fields · synced May 18, 2026
  • EUDAMED 038b59f2-e84f-4271-8d09-1b6fb0ce310d 61 fields · synced May 19, 2026