BEUDAMED
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    AVA Sciences-FMTC LLC

    Manufacturer
    🇨🇭 Switzerland

    Jeisys Medical Inc.

    Manufacturer
    🇰🇷 South Korea·3 Basic UDI-DIs·3 Devices·1 Importer·MTIC InterCert S.r.l., Kiwa Belgelendirme Hizmetleri A.Ş., and MTIC InterCert S.r.l.

    Wellysis Corp.

    Manufacturer
    🇰🇷 South Korea·1 Basic UDI-DI·1 Device·MTIC InterCert S.r.l.

    Sonotrip V20

    Device
    EU MDD · Eu Md Class 2b ·Jeisys Medical Inc.·No longer on the market

    POTENZA

    Device
    EU MDD · Eu Md Class 2b ·Jeisys Medical Inc.·On the market·1 country

    GENERAL PURPOSE ELECTROCARDIOGRAPHS

    Device
    EU MDD · Eu Md Class 2a ·Wellysis Corp.·On the market·5 countries

    0068/QCO-DM/310-2021

    Certificate
    MDD Annex II (excluding section 4)·Jeisys Medical Inc.·MTIC InterCert S.r.l.·1 Basic UDI-DI

    0068/QCO-DM/226-2020

    Certificate
    MDD Annex II (excluding section 4)·Jeisys Medical Inc.·MTIC InterCert S.r.l.·1 Basic UDI-DI

    0068/QCO-DM/165-2020

    Certificate
    MDD Annex II (excluding section 4)·Wellysis Corp.·MTIC InterCert S.r.l.·1 Basic UDI-DI

    Sonotrip V20

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·Jeisys Medical Inc.·1 device

    POTENZA

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·Jeisys Medical Inc.·1 device

    S-Patch Ex

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Wellysis Corp.·1 device