BEUDAMED
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    Filters Authorized Representative: Advena Limited × Notified Body: Polskie Centrum Badan I Certyfikacji S.A. × Clear all

    Eclipse Medical Co. Ltd

    Manufacturer
    🇹🇭 Thailand·23 Basic UDI-DIs·23 Devices·1 Importer·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    SurePulse Medical Ltd.

    Manufacturer
    15 Basic UDI-DIs·15 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    MEDI J Co., Ltd

    Manufacturer
    🇰🇷 South Korea·2 Basic UDI-DIs·2 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    Wever Instruments. Co., Ltd.

    Manufacturer
    🇰🇷 South Korea·1 Basic UDI-DI·1 Device·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    1434-MDD-176/2021

    Certificate
    MDD Annex II Section 4·Eclipse Medical Co. Ltd·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·13 Basic UDI-DIs

    1434-MDD-178/2021

    Certificate
    MDD Annex II Section 4·Eclipse Medical Co. Ltd·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·10 Basic UDI-DIs

    1434-MDD-297/2020

    Certificate
    MDD Annex II (excluding section 4)·SurePulse Medical Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·14 Basic UDI-DIs

    1434-MDD-070/2021

    Certificate
    MDD Annex II (excluding section 4)·MEDI J Co., Ltd·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·2 Basic UDI-DIs

    1434-MDD-297/2020

    Certificate
    MDD Annex II (excluding section 4)·SurePulse Medical Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

    1434-MDD-177/2021

    Certificate
    MDD Annex II (excluding section 4)·Eclipse Medical Co. Ltd·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·13 Basic UDI-DIs

    1434-MDD-179/2021

    Certificate
    MDD Annex II (excluding section 4)·Eclipse Medical Co. Ltd·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·10 Basic UDI-DIs

    1434-MDD-446/2020

    Certificate
    MDD Annex II (excluding section 4)·Wever Instruments. Co., Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

    ChekFLO Vascular Plug II – 10 mm

    Device
    EU MDD · Eu Md Class 2b ·Eclipse Medical Co. Ltd·On the market·1 country

    ChekFLO Vascular Plug II – 8 mm

    Device
    EU MDD · Eu Md Class 2b ·Eclipse Medical Co. Ltd·On the market·1 country

    ChekFLO Vascular Plug II – 6 mm

    Device
    EU MDD · Eu Md Class 2b ·Eclipse Medical Co. Ltd·On the market·1 country

    ChekFLO Vascular Plug II – 4 mm

    Device
    EU MDD · Eu Md Class 2b ·Eclipse Medical Co. Ltd·On the market·1 country

    OMEGA LAA Occluder 16mm

    Device
    EU MDD · Eu Md Class 3 ·Eclipse Medical Co. Ltd·On the market·10 countries

    OMEGA LAA Occluder 14mm

    Device
    EU MDD · Eu Md Class 3 ·Eclipse Medical Co. Ltd·On the market·10 countries

    OMEGA LAA Occluder Delivery System 14F

    Device
    EU MDD · Eu Md Class 3 ·Eclipse Medical Co. Ltd·On the market·10 countries

    OMEGA LAA Occluder 30mm

    Device
    EU MDD · Eu Md Class 3 ·Eclipse Medical Co. Ltd·On the market·10 countries