BEUDAMED
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    ISE Reference Solution Kit

    FDA UDI
    Diamond Diagnostics Inc.·00811403011759·

    RAPIDPOINT® 350 Sensor Module

    FDA UDI
    Siemens Healthcare Diagnostics Inc.·00630414566337·RAPIDPOINT® 350 Sensor Module, an in vitro diag...

    Ready Sensor™ GOLD Reference Sensor

    FDA UDI
    Siemens Healthcare Diagnostics Inc.·00630414112206·Ready Sensor™ Reference Biosensor. An in vitro ...

    ISE Internal Reference Solution

    FDA UDI
    Diamond Diagnostics Inc.·00811403012589·

    CardioKey, Model CK100

    FDA registration
    SEMECS, S.R.O.·1 product·🇸🇰 Slovakia

    ePatch, ePatch ECG Recorder, ECG Recorder, ePatch 2

    FDA registration
    SEMECS, S.R.O.·1 product·🇸🇰 Slovakia

    Braemar Telemetry Patch System BTPS-1000, MCOT, Braemar Telemetry Patch System, BTPS-1000, ECG Recorder, BTP-1000M (Moni

    FDA registration
    SEMECS, S.R.O.·1 product·🇸🇰 Slovakia

    DSL DHEA (DSL 8900)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    HEMATOLOGY ANALYZER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

    FDA Pre-Market Approval
    FDA Class 3 ·LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software

    Kit, Test, In Vitro Periodontal

    FDA Pre-Market Approval
    FDA Class 3 ·PERIOCHECK TM ENZYME ACTIVITY TEST KIT

    Kit, Test, In Vitro Periodontal

    FDA Pre-Market Approval
    FDA Class 3 ·PERIOCHECK TM ENZYME ACTIVITY TEST KIT

    LeukoStrat CDx FLT3 Mutation Assay

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Invivoscribe, Inc.·2 devices

    IMM Deutschland UG

    Importer
    🇩🇪 Germany·1 Manufacturer

    Alinity i CA 19-9XR Controls

    FDA registration
    Fujirebio Diagnostics, Inc.·1 product·🇺🇸 United States

    Alinity i BNP Calibrators

    FDA registration
    Fujirebio Diagnostics, Inc.·1 product·🇺🇸 United States

    Alinity i CA 125II Reagent Kit

    FDA registration
    Fujirebio Diagnostics, Inc.·1 product·🇺🇸 United States

    Alinity c Urine/CSF Protein Reagent Kit

    FDA registration
    Fisher Diagnostics·1 product·🇺🇸 United States

    Chest Drainage Bag (MDL 005/185/010) or (MDL 005/185/012)

    FDA registration
    Command Medical Products, LLC.·1 product·🇺🇸 United States

    Sterigenics US LLC

    FDA registration
    Sterigenics US LLC·1 product·🇺🇸 United States