BEUDAMED
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    Weight Bear

    FDA UDI
    Orthios Innovations Llc·00860012977413·A device for simulating a weightbearing positio...

    Weight Bear

    FDA UDI
    Orthios Innovations Llc·00198168799079·A device for simulating a weightbearing positio...

    Weight Bear Accessory Wedge

    FDA UDI
    Orthios Innovations Llc·00860012977420·Accessory wedges for use with the Weight Bear. ...

    Weight Bear

    FDA UDI
    Orthios Innovations Llc·00860012977406·A device for simulating a weightbearing positio...

    enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM) v8.06 --- For in vitro quantitative measurement of a variety of analytes of clinical interest --- Background: The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TCAutomation) for pre-analytical and post-analytical sample and data management. In addition to an Automated Track Sub-system, the enGen (TM) System includes one or more VITROS Chemistry, Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware), and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·June 11, 2014

    Ortho Organizers GmbH

    Importer
    🇩🇪 Germany·34 Manufacturers

    MedEnvoy Global BV

    Authorized representative
    🇳🇱 Netherlands·143 Manufacturers·2306 Devices

    CEpartner4U

    Authorized representative
    🇳🇱 Netherlands·160 Manufacturers·5787 Devices

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices

    mdi Europa GmbH

    Authorized representative
    🇩🇪 Germany·132 Manufacturers·4741 Devices

    Stryker EMEA Supply Chain Services BV

    Importer
    🇳🇱 Netherlands·48 Manufacturers

    Advena Limited

    Authorized representative
    🇲🇹 Malta·467 Manufacturers·13717 Devices

    Obelis s.a.

    Authorized representative
    🇧🇪 Belgium·546 Manufacturers·18515 Devices

    CMC Medical Devices & Drugs SL

    Authorized representative
    🇪🇸 Spain·698 Manufacturers·11260 Devices

    MedPath GmbH

    Authorized representative
    🇩🇪 Germany·537 Manufacturers·13464 Devices