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    CoaguSense Inc.

    Manufacturer
    🇺🇸 United States·4 Basic UDI-DIs·4 Devices·BSI Assurance UK Ltd, BSI Assurance UK Ltd, and BSI Assurance UK Ltd

    Ortho Solutions, LC d/b/a DynaFlex

    Manufacturer
    🇺🇸 United States·2 Importers

    ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Multi Purpose 02

    Device
    EU MDD · Eu Md Class 3 ·ASAHI INTECC CO., LTD.·No longer on the market·30 countries

    BT KINISI 7 3/4 LH FW

    Device
    EU MDR · Eu Md Class 1 ·Hugh Steeper Limited·On the market

    ASAHI ZenyteEX PTCA GUIDING CATHETER

    Device
    EU MDD · Eu Md Class 3 ·ASAHI INTECC CO., LTD.·On the market·30 countries

    Su-Por® Surgical Implants

    Device
    EU MDD · Eu Md Class 2b ·Poriferous, LLC·On the market·32 countries

    STERiLANCE

    Device
    EU MDR · Eu Md Class 2a ·Sterilance Medical (Suzhou) Inc.·Not intended for eu market

    ASAHI Hyperion Coronary Guide Catheter

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·ASAHI INTECC CO., LTD.·1 device

    Marketlab, Inc.

    Manufacturer
    🇺🇸 United States·3 Importers

    Vedia Solutions Division Of Laxmi Dental Export Pvt Ltd

    Manufacturer
    🇮🇳 India·3 Basic UDI-DIs·86 Devices

    Microbrush International

    Manufacturer
    🇺🇸 United States·9 Basic UDI-DIs·52 Devices

    MD 662930

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·CoaguSense Inc.·BSI Assurance UK Ltd·2 Basic UDI-DIs

    0086

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·CoaguSense Inc.·BSI Assurance UK Ltd·1 Basic UDI-DI

    MD662930

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·CoaguSense Inc.·BSI Assurance UK Ltd·1 Basic UDI-DI

    Coag-Sense Prothrombin Time (PT) /INR Monitoring System

    Device
    EU IVDD · Eu Ivd General ·CoaguSense Inc.·On the market

    Coag-Sense Prothrombin Time (PT)/INR Test Strip Kit

    Device
    EU IVDD · Eu Ivd General ·CoaguSense Inc.·On the market

    Coag-Sense Prothrombin Time (PT)/INR Test Strip Kit

    Device
    EU IVDD · Eu Ivd General ·CoaguSense Inc.·On the market

    Coag-Sense Control Test Strip Kit - 10 Count

    Device
    EU IVDD · Eu Ivd General ·CoaguSense Inc.·On the market

    Taglus PU Flex

    Device
    EU MDR · Eu Md Class 1 ·Vedia Solutions Division Of Laxmi Dental Export Pvt Ltd·On the market

    Taglus PU Flex

    Device
    EU MDR · Eu Md Class 1 ·Vedia Solutions Division Of Laxmi Dental Export Pvt Ltd·On the market·32 countries