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

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    EKLA CORPORATION

    FDA registration
    EKLA CORPORATION·5 products·🇺🇸 United States

    HCG RAPID TEST

    FDA Adverse Event
    Malfunction ·EKLA CORPORATION·Product code DHA·October 21, 2016

    VDTS-100R

    FDA Adverse Event
    Malfunction ·EKLA CORPORATION·Product code FLL·August 5, 2025

    NOVAPLUS DIGITAL THERMOMETER

    FDA Adverse Event
    Malfunction ·EKLA CORPORATION·Product code FLL·March 20, 2020

    NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pregnancy test

    FDA Recall
    Terminated ·Ekla Corporation·Product code JHI·October 20, 2016

    NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pregnancy test

    FDA Enforcement
    Class II ·Terminated·Ekla Corporation·July 18, 2018

    NOVAPLUS DIGITAL THERMOMETER, PEDIATRIC, DUCK CAP

    FDA Adverse Event
    Malfunction ·ELKA CORPORATION·Product code FLL·August 25, 2022

    CMC Medical Devices & Drugs SL

    Authorized representative
    🇪🇸 Spain·698 Manufacturers·11260 Devices