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Prealbumin Reagent Kit（immunoturbidimetric Method）

EUDAMED

Class IVD General (EU MDR)

Ref 3016556Model R1: 1x50mL, R2: 1x10mL,Calibration sample: 0.8mLRef 3021196Ref 3023196

by Dirui Industrial Co., Ltd

Identity

Trade Name
PREALBUMIN REAGENT KIT（IMMUNOTURBIDIMETRIC METHOD） EUDAMED
Device Name
PREALBUMIN REAGENT KIT（IMMUNOTURBIDIMETRIC METHOD） EUDAMED
Model / Reference
R1: 1x50mL, R2: 1x10mL,Calibration sample: 0.8mL EUDAMED
3016556 EUDAMED
3021196 EUDAMED
3023196 EUDAMED

Identifiers

Primary DI / UDI-DI
06942202258961 EUDAMED
06942202258954 EUDAMED
06942202213434 EUDAMED
Basic UDI-DI
B-06942202258961 EUDAMED
B-06942202258954 EUDAMED
B-06942202213434 EUDAMED
EMDN Code
W0102010305 PRE-ALBUMIN / TRANSTHYRETIN 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

Prealbumin Reagent Kit（immunoturbidimetric Method） 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 (3)

  • EUDAMED 749df8e1-2866-4730-bbdc-483cfb3aa7f7 61 fields · synced Jul 16, 2026
  • EUDAMED de4ff75c-f36b-499c-9ad2-8113e16f946d 61 fields · synced May 18, 2026
  • EUDAMED 316a6a83-db6c-4637-a0ed-8eedd97a0771 61 fields · synced May 18, 2026