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    CAIRN DIAGNOSTICS

    FDA registration
    CAIRN DIAGNOSTICS·1 product·🇺🇸 United States

    13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended for use in the measurement of the rate of gastric emptying of solids and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in adult humans who are symptomatic for gastroparesis.

    FDA Recall
    Terminated ·Cairn Diagnostics·Product code PGE·January 8, 2021

    13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended for use in the measurement of the rate of gastric emptying of solids and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in adult humans who are symptomatic for gastroparesis.

    FDA Enforcement
    Class II ·Terminated·Cairn Diagnostics·February 24, 2021

    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...

    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

    BREAST IMPLANT

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON / MENTOR WORLDWIDE LLC·Product code FTR·February 26, 2020

    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

    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

    MPS Medical Product Service GmbH

    Authorized representative
    🇩🇪 Germany·35 Manufacturers·1959 Devices

    SUNGO Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·1571 Manufacturers·20390 Devices