BEUDAMED
    22 results · 53ms · Sources: EU EUDAMED, US FDA

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    CAIRE Diagnostics Inc.

    Manufacturer
    🇺🇸 United States·2 Basic UDI-DIs·2 Devices·1 Importer

    Fenom Pro

    Device
    EU IVDR · Eu Ivd Class A ·CAIRE Diagnostics Inc.·On the market

    Fenom Pro

    Device
    EU MDR · Eu Md Class 1 ·CAIRE Diagnostics Inc.·On the market·0 countries

    CAIRE Diagnostics

    FDA UDI
    Caire Diagnostics Inc.·00860008017918·Package contains: Fenom Pro Device - P/N 900-00...

    CAIRE Diagnostics

    FDA UDI
    Caire Diagnostics Inc.·00860008017932·Package contains: Fenom Pro Device - P/N 900-00...

    CAIRE Diagnostics

    FDA UDI
    Caire Diagnostics Inc.·00860008017956·Box of 50 Fenom Pro Mouthpieces, PN 810-0006 So...

    CAIRE Diagnostics

    FDA UDI
    Caire Diagnostics Inc.·00860008017901·Package contains: External Power Supply, P/N 19...

    CAIRE Diagnostics

    FDA UDI
    Caire Diagnostics Inc.·00860008017949·Package contains: Fenom Pro Device - P/N 900-00...

    CAIRE Diagnostics

    FDA UDI
    Caire Diagnostics Inc.·00860008017925·Package contains: Fenom Pro Device - P/N 900-00...

    EQUINOX

    FDA Adverse Event
    Malfunction ·CAIRE INC.·Product code CAW·April 24, 2020

    Fractional Exhaled Nitric Oxide Breath Analyzer

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·CAIRE Diagnostics Inc.·1 device

    Fenom Pro Mouthpiece

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·CAIRE Diagnostics Inc.·1 device

    CAIRE Medical Germany GmbH

    Importer
    🇩🇪 Germany·2 Manufacturers

    CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. Fenom Pro should not be used in critical care, emergency care or in anesthesiology.

    FDA Recall
    Terminated ·CAIRE DIAGNOSTICS INC·Product code MXA·February 26, 2021

    CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. Fenom Pro should not be used in critical care, emergency care or in anesthesiology.

    FDA Enforcement
    Class II ·Terminated·CAIRE DIAGNOSTICS INC·March 31, 2021

    MPS Medical Product Service GmbH

    Authorized representative
    🇩🇪 Germany·35 Manufacturers·1959 Devices

    EIA Test Kit

    FDA UDI
    CRITICAL CARE DIAGNOSTICS, INC.·00867556000188·

    Presage ST2 Assay Kit

    FDA UDI
    CRITICAL CARE DIAGNOSTICS, INC.·00867556000195·

    EIA Test Kit

    FDA UDI
    CRITICAL CARE DIAGNOSTICS, INC.·00867556000157·

    PRESAGE ST2 Controls Kit

    FDA UDI
    CRITICAL CARE DIAGNOSTICS, INC.·00867556000171·