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Cystatin C Reagent Kit（latex Enhanced Immunoturbidimetric Assay）

EUDAMED

Class IVD General (EU MDR)

Ref 3021608Model R1: 1x60mL, R2: 1x20mLRef 3021607Model R1: 1x60mL, R2: 1x20mL, Calibration sample: 5x0.3mL, Control: 2x0.5mLRef 3023550

by Dirui Industrial Co., Ltd

Identity

Trade Name
CYSTATIN C REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY） EUDAMED
Device Name
CYSTATIN C REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY） EUDAMED
Model / Reference
R1: 1x60mL, R2: 1x20mL EUDAMED
3021608 EUDAMED
R1: 1x60mL, R2: 1x20mL, Calibration sample: 5x0.3mL, Control: 2x0.5mL EUDAMED
3021607 EUDAMED
3023550 EUDAMED

Identifiers

Primary DI / UDI-DI
06925794592521 EUDAMED
06925794592514 EUDAMED
06942202216091 EUDAMED
Basic UDI-DI
B-06925794592521 EUDAMED
B-06925794592514 EUDAMED
B-06942202216091 EUDAMED
EMDN Code
W0102019008 CYSTATIN C EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Austria EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

Yes

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

Cystatin C Reagent Kit（latex Enhanced 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 b8238886-4cfc-4e38-8135-18eb3ecf8b64 61 fields · synced Oct 6, 2026
  • EUDAMED c53464a7-450f-4914-b609-8f10a5001853 61 fields · synced May 18, 2026
  • EUDAMED 7595f965-89cf-4bf6-bc5c-2dd547bcb595 61 fields · synced May 19, 2026