BEUDAMED
    32 results · 69ms · Sources: EU EUDAMED, US FDA

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    Innova Medical Group, Inc.

    Manufacturer
    🇺🇸 United States

    COVID-19 SELF-TEST (RAPID ANTIGEN TEST)

    FDA Adverse Event
    Malfunction ·INNOVA MEDICAL GROUP, INC.·Product code QKO·June 15, 2021

    INNOVA SARS COV2 ANTIGEN RAPID QUALITATIVE TEST

    FDA Adverse Event
    Malfunction ·INNOVA MEDICAL GROUP, INC·Product code QKP·October 21, 2022

    For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT1309

    FDA Recall
    Open, Classified ·INNOVA MEDICAL GROUP, INC.·Product code QKP·April 9, 2021

    COVID-19 Self-Test Kit *** INNOVA *** 3T

    FDA Recall
    Open, Classified ·INNOVA MEDICAL GROUP, INC.·Product code QKP·April 9, 2021

    COVID-19 Self-Test Kit *** INNOVA *** 7T

    FDA Recall
    Open, Classified ·INNOVA MEDICAL GROUP, INC.·Product code QKP·April 9, 2021

    For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT1309

    FDA Enforcement
    Class I ·Ongoing·INNOVA MEDICAL GROUP, INC.·June 16, 2021

    COVID-19 Self-Test Kit *** INNOVA *** 7T

    FDA Enforcement
    Class I ·Ongoing·INNOVA MEDICAL GROUP, INC.·June 16, 2021

    COVID-19 Self-Test Kit *** INNOVA *** 3T

    FDA Enforcement
    Class I ·Ongoing·INNOVA MEDICAL GROUP, INC.·June 16, 2021

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices

    Lotus NL B.V.

    Authorized representative
    🇳🇱 Netherlands·584 Manufacturers·21427 Devices

    CS Life Sciences Europe Ltd

    Authorized representative
    🇮🇪 Ireland·35 Manufacturers·444 Devices

    International Associates Auditing & Certification Limited

    Authorized representative
    🇮🇪 Ireland·46 Manufacturers·161 Devices

    Kalms Consulting GmbH

    Importer
    🇩🇪 Germany·8 Manufacturers

    Medical Technology Promedt Consulting GmbH

    Authorized representative
    🇩🇪 Germany·194 Manufacturers·10009 Devices

    QbD RepS BV

    Authorized representative
    🇧🇪 Belgium·86 Manufacturers·1555 Devices

    CEpartner4U

    Authorized representative
    🇳🇱 Netherlands·160 Manufacturers·5787 Devices

    mdi Europa GmbH

    Authorized representative
    🇩🇪 Germany·132 Manufacturers·4741 Devices

    Advena Limited

    Authorized representative
    🇲🇹 Malta·467 Manufacturers·13717 Devices

    MDSS GmbH

    Authorized representative
    🇩🇪 Germany·388 Manufacturers·16562 Devices