BEUDAMED
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    Otsuka America Pharmaceutical, Inc

    FDA registration
    Otsuka America Pharmaceutical, Inc·2 products·🇺🇸 United States

    Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA

    FDA UDI
    Otsuka America Pharmaceutical Inc·00857335005077·The web based application for calculating pedia...

    BreathTek® UBT for H. pylori Kit (Metabolic Solutions Kit)

    FDA UDI
    Otsuka America Pharmaceutical Inc·00857335005039·This is the Metabolic Solutions Kit version of ...

    MyCite Patch

    FDA UDI
    Otsuka America Pharmaceutical Inc·00857335005053·DW5 replacement patch

    BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit)

    FDA UDI
    Otsuka America Pharmaceutical Inc·00857335005008·The BreathTek® UBT for H. pylori Kit (BreathTek...

    MyCite Patch

    FDA UDI
    Otsuka America Pharmaceutical Inc·00857335005091·2 component patch RW2

    Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA

    FDA UDI
    Otsuka America Pharmaceutical Inc·00857335005015·The web based application for calculating pedia...

    UBIT (13C-UREA) TABLET, 100MG MILLIGRAM(S)

    FDA Adverse Event
    OTSUKA AMERICA PHARMACEUTICAL INC.·Product code MSQ·August 3, 2012

    BREATH TEK FOR H. PYLORI

    FDA Adverse Event
    Injury ·OTSUKA AMERICA PHARMACEUTICAL INC.·Product code OZA·January 8, 2019

    UBIT (13C-UREA)

    FDA Adverse Event
    OTSUKA AMERICA PHARMACEUTICAL INC.·Product code MSQ·July 3, 2013

    BREATH TEK UBT KIT

    FDA Adverse Event
    Injury ·OTSUKA AMERICA PHARMACEUTICAL INC.·Product code MSQ·April 7, 2015

    UBiT-IR300 Infrared Spectrophotometer, Software Versions 7.0, 7.01 and 7.11.

    FDA Recall
    Terminated ·Otsuka America Pharmaceutical, Inc.·Product code JJQ·January 18, 2008

    BREATHTEK UBT KIT

    FDA Adverse Event
    Injury ·OTSUKA AMERICA PHARMACEUTICALS, INC.·Product code MSQ·October 24, 2017

    BREATHTEK (UBT)

    FDA Adverse Event
    Injury ·OTSUKA AMERICA PHARMACEUTICALS INC.·Product code MSQ·April 28, 2011

    BREATHTEK UBT KIT

    FDA Adverse Event
    Injury ·OTSUKA AMERICA PHARMACEUTICALS, INC.·Product code MSQ·September 29, 2016

    BREATH TEK UBT KIT

    FDA Adverse Event
    Other ·OTSUKA AMERICA PHARMACEUTICALS INC.·Product code MSQ·April 14, 2015

    BREATHTEK (UBT)

    FDA Adverse Event
    Injury ·OTSUKA AMERICA PHARMACEUTICAL COMPANY, INC. (OAPI)·Product code MSQ·May 28, 2009

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices

    Medical Technology Promedt Consulting GmbH

    Authorized representative
    🇩🇪 Germany·194 Manufacturers·10009 Devices