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    Filters Competent Authority: Federal Agency For Medicines And Health Products / / Health Products Division × Notified Body: 3 Ec International A.S. × Clear all

    NEXTBIOMEDICAL CO., LTD.

    Manufacturer
    🇰🇷 South Korea·12 Basic UDI-DIs·14 Devices·3 Importers·3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., and 3EC International a.s.

    Dalim Tissen Co., Ltd.

    Manufacturer
    🇰🇷 South Korea·37 Basic UDI-DIs·87 Devices·1 Importer·3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and 3EC International a.s.

    2019-MDD/QS-088/A, 2019-MDD/DE-009/A

    Certificate
    MDD Annex II Section 4·Dalim Tissen Co., Ltd.·3EC International a.s.·9 Basic UDI-DIs

    2019-MDD/QS-006/A, 2019-MDD/DE-007/A

    Certificate
    MDD Annex II Section 4·Dalim Tissen Co., Ltd.·3EC International a.s.·9 Basic UDI-DIs

    2019-MDD/QS-006/A, 2019-MDD/DE-007/A

    Certificate
    MDD Annex II Section 4·Dalim Tissen Co., Ltd.·3EC International a.s.·1 Basic UDI-DI

    2021-MDD/DE-053

    Certificate
    MDD Annex II Section 4·NEXTBIOMEDICAL CO., LTD.·3EC International a.s.·1 Basic UDI-DI

    2018-MDD/DE-033/C

    Certificate
    MDD Annex II Section 4·NEXTBIOMEDICAL CO., LTD.·3EC International a.s.·2 Basic UDI-DIs

    2021-MDD/QS-052

    Certificate
    MDD Annex II (excluding section 4)·NEXTBIOMEDICAL CO., LTD.·3EC International a.s.·1 Basic UDI-DI

    2018-MDD/QS-032/C

    Certificate
    MDD Annex II (excluding section 4)·NEXTBIOMEDICAL CO., LTD.·3EC International a.s.·3 Basic UDI-DIs

    2020-MDD/QS-037/A

    Certificate
    MDD Annex II (excluding section 4)·NEXTBIOMEDICAL CO., LTD.·3EC International a.s.·5 Basic UDI-DIs

    2018-MDD/QS-034C

    Certificate
    MDD Annex II (excluding section 4)·NEXTBIOMEDICAL CO., LTD.·3EC International a.s.·1 Basic UDI-DI

    Nexsphere-F™

    Device
    EU MDD · Eu Md Class 3 ·NEXTBIOMEDICAL CO., LTD.·On the market·11 countries

    Nexpowder™

    Device
    EU MDD · Eu Md Class 3 ·NEXTBIOMEDICAL CO., LTD.·On the market·18 countries

    Nexpowder™

    Device
    EU MDD · Eu Md Class 3 ·NEXTBIOMEDICAL CO., LTD.·On the market·18 countries

    Rapi-Gide(Plug type)

    Device
    EU MDD · Eu Md Class 3 ·Dalim Tissen Co., Ltd.·On the market·4 countries

    Rapi-Gide(Plug type)

    Device
    EU MDD · Eu Md Class 3 ·Dalim Tissen Co., Ltd.·On the market·4 countries

    Rapiderm

    Device
    EU MDD · Eu Md Class 3 ·Dalim Tissen Co., Ltd.·On the market·10 countries

    Diaderm Tape

    Device
    EU MDD · Eu Md Class 3 ·Dalim Tissen Co., Ltd.·On the market·10 countries

    Rapiderm

    Device
    EU MDD · Eu Md Class 3 ·Dalim Tissen Co., Ltd.·On the market·10 countries

    Rapiderm

    Device
    EU MDD · Eu Md Class 3 ·Dalim Tissen Co., Ltd.·On the market·10 countries