BEUDAMED
    43 results · 27ms · Sources: EU EUDAMED, US FDA

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    DEA SRL

    Manufacturer
    🇮🇹 Italy

    DEAS S.r.l.

    Manufacturer
    🇮🇹 Italy

    DIA-CHEM S.r.l.

    Authorized representative
    🇮🇹 Italy

    VER SAN & DAFNE MD SRL

    Importer
    🇮🇹 Italy·4 Manufacturers

    Sorin Group Italia S.r.L.

    Authorized representative
    🇮🇹 Italy·1 Manufacturer

    DEA SRL

    System producer
    🇮🇹 Italy

    impremed spa

    System producer
    🇮🇹 Italy

    BETATEX SPA

    System producer
    🇮🇹 Italy

    GIMA SPA

    System producer
    🇮🇹 Italy

    Estor SpA

    System producer
    🇮🇹 Italy

    ELESTA SpA

    System producer
    🇮🇹 Italy

    Eurosirel spa

    System producer
    🇮🇹 Italy

    CARDIOLINE SpA

    System producer
    🇮🇹 Italy

    Malvestio Spa

    System producer
    🇮🇹 Italy

    REF 4890 SMARTSCRAPER CE0123, STERILE EO. Used in oral surgery.

    FDA Enforcement
    Class II ·Terminated·Meta C.G.M. Spa·June 9, 2021

    REF: 3598 SAFESCRAPER TWIST, CE 0123, STERILE EO. Used in oral surgery.

    FDA Enforcement
    Class II ·Terminated·Meta C.G.M. Spa·June 9, 2021

    Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.

    FDA Enforcement
    Class II ·Terminated·Sentinel CH SpA·November 4, 2015

    MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems The product is a medical device (chemistry reagent) and is intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems. The kit is provided as a ready to use liquid material consisting in two components: Reagent 1 and Reagent 2. According to the catalogue number, the kit is composed of three vials of 48 ml for Reagent 1 and three vials of 18 ml for Reagent 2 in the configuration 8L24-31. The configuration 8L24-41 consists in ten vials of 90 ml for Reagent 1 and ten vials of 34 ml for Reagent 2

    FDA Enforcement
    Class II ·Terminated·Sentinel CH SPA·August 9, 2017

    Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 08P5320

    FDA Enforcement
    Class II ·Terminated·Sentinel CH SpA·October 2, 2019

    MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 8L25-30

    FDA Enforcement
    Class II ·Terminated·Sentinel CH SpA·October 2, 2019