BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    Filters Country: Sweden ×

    Wellspect HealthCare (a division of Dentsply IH AB)

    Manufacturer
    🇸🇪 Sweden

    AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    Chlamydia Test

    FDA Enforcement
    Class II ·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025

    Dentsply IH AB

    Importer
    🇸🇪 Sweden

    LoFric Origo, Nelaton, 16in, FR10 urinary catheters

    FDA Enforcement
    Class II ·Terminated·Wellspect HealthCare (Division of DENTSPLY IH AB)·July 29, 2020

    LoFric Origo, Tiemann, 16in, FR12 urinary catheters

    FDA Enforcement
    Class II ·Terminated·Wellspect HealthCare (Division of DENTSPLY IH AB)·July 29, 2020

    LoFric Origo, Tiemann, 16in, FR14 urinary catheters

    FDA Enforcement
    Class II ·Terminated·Wellspect HealthCare (Division of DENTSPLY IH AB)·July 29, 2020