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Wiener Laboratorios SAIC

Active in EUDAMED

Argentinafrom SRN EUDAMED SRN AR-MF-000023605

Devices
84
Registrations
EUDAMED

What Wiener Laboratorios SAIC makes

Wiener Laboratorios SAIC produces in vitro diagnostic (IVD) reagents and consumables for coagulation testing, including coagulation control products, chromogenic substrates like Chrom ATIII, and automated testing modules such as the CMD 80 Detergent and CM 160i. The company also manufactures urine analysis strips (WIENER LAB. URINE STRIP 10 AND 11), buffers like Imidazole, and cleaning solutions for laboratory equipment, such as the WL 19 E-Z Cleanser AA and Acid Solution. Additional products include APTTest reagents for activated partial thromboplastin time (APTT) testing and specialized modules like the CMD 600 Reagent Module LT.

Wiener Laboratorios SAIC’s diagnostic devices are classified under Class A and Class II regulations, with some falling under the broader IVD General category. These products are listed in the EU’s eudamed registry and have undergone 510(k) clearance through the FDA. The company is based in Argentina.

AI-generated from registry data, 19 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue84

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  • ISE Reagent Module Ref 1572570

    Class A
    Withdrawn CE IVDR, withdrawn EUDAMED A

  • CM 260i Ref 9351064

    Class A
    Withdrawn CE IVDR, withdrawn EUDAMED A

  • Fibrinógeno Ref 1705006

    IVD General
    Active CE IVDD EUDAMED IVD General

  • WL 19 Rinse AA Ref 1474515

    Class A
    Withdrawn CE IVDR, withdrawn EUDAMED A

  • Anticoagulante W Ref 1898552

    Class A
    Withdrawn CE IVDR, withdrawn EUDAMED A

  • Noión Ref 1999551

    Class A
    Withdrawn CE IVDR, withdrawn EUDAMED A

  • WL Lyse Ref 1474539

    Class A
    Withdrawn CE IVDR, withdrawn EUDAMED A

  • Fibrinogen Ref 42004

    IVD General
    Active CE IVDD EUDAMED IVD General

  • Anticoagulante TP Ref 1895002

    Class A
    Withdrawn CE IVDR, withdrawn EUDAMED A

  • CM Series Reagent Module LT Ref 1008155

    Class A
    Withdrawn CE IVDR, withdrawn EUDAMED A

  • Plasma Control Patológico Ref 1937002

    IVD General
    Withdrawn CE IVDD, withdrawn EUDAMED IVD General

  • Cm 160 Ref 9351061

    Class A
    Withdrawn CE IVDR, withdrawn EUDAMED A

  • CMD 80 Detergent Ref 1009676

    Class A
    Withdrawn CE IVDR, withdrawn EUDAMED A

  • Albúmina bovina 30% Ref 1443151

    Class A
    Withdrawn CE IVDR, withdrawn EUDAMED A

  • CMD 600 Cleaning Solution Ref 1009903

    Class A
    Withdrawn CE IVDR, withdrawn EUDAMED A

  • CM 320i Ref 9351066

    Class A
    Withdrawn CE IVDR, withdrawn EUDAMED A

  • Tw Aa Ref 1979002

    Class A
    Withdrawn CE IVDR, withdrawn EUDAMED A

  • Solución de Limpieza SE Ref 1958003

    Class A
    Withdrawn CE IVDR, withdrawn EUDAMED A

  • Solución Desproteinizante Ref 1958001

    Class A
    Withdrawn CE IVDR, withdrawn EUDAMED A

  • Cm 320 Ref 9351065

    Class A
    Withdrawn CE IVDR, withdrawn EUDAMED A

  • Soluplastin Ref 1705005

    IVD General
    Withdrawn CE IVDD, withdrawn EUDAMED IVD General

  • Tensioactive Ref 1999719

    Class A
    Withdrawn CE IVDR, withdrawn EUDAMED A

  • Wiener lab. CM 250 Ref 9351018

    Class A
    Active CE IVDR EUDAMED A

  • HbA1c enzymatic Lysis buffer Ref 1999729

    Class A
    Withdrawn CE IVDR, withdrawn EUDAMED A

  • Control Plasma Pathologic Ref 42006

    IVD General
    Active CE IVDD EUDAMED IVD General

  • WL Diluent Ref 1474537

    Class A
    Withdrawn CE IVDR, withdrawn EUDAMED A

  • Control Plasma Normal Ref 42005

    IVD General
    Active CE IVDD EUDAMED IVD General

  • WL 19 Rinse AA Ref 1474511

    Class A
    Withdrawn CE IVDR, withdrawn EUDAMED A

  • CMD 600 Urine Diluent Ref 1009902

    Class A
    Withdrawn CE IVDR, withdrawn EUDAMED A

  • Prothrombin Time Ref 42001

    IVD General
    Active CE IVDD EUDAMED IVD General

  • CMD Urine Quality Control Ref 1009665

    Class A
    Withdrawn CE IVDR, withdrawn EUDAMED A

  • e32 Ref 9351058

    Class A
    Active CE IVDR EUDAMED A

  • Coagulation Calibrator Ref 42007

    IVD General
    Active CE IVDD EUDAMED IVD General

  • COR Cleanser Ref 1705008

    Class A
    Withdrawn CE IVDR, withdrawn EUDAMED A

Rows 51-84 of 84

Showing 51-84 of 84

Company details

EUDAMED SRN
AR-MF-000023605
EU VAT number
30522228210
EUDAMED status
Active
EUDAMED registered name
Wiener Laboratorios SAIC
EUDAMED abbreviated name
Wiener lab
Registered address
2944, Riobamba, 2000, Rosario, Argentina
Phone
+54 341 432 9191
PRRC contact
Viviana Cetola(public in EUDAMED)

From the company website

Read 18 Sep 2026

We are the largest in vitro diagnostic industry in Latin America and our product portfolio has a wide range of comprehensive solutions for laboratorios of clinical analysis of various sizes.

Translated from the manufacturer's own website. Source