BEUDAMED
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    BNC KOREA, Inc.

    Manufacturer
    🇰🇷 South Korea·60 Basic UDI-DIs·60 Devices·3EC International a.s., 3EC International a.s., and 3EC International a.s.

    Shenzhen Kentro Medical Electronics CO.,LTD.

    Manufacturer
    🇨🇳 China·5 Basic UDI-DIs·16 Devices·2 Importers·Intertek Medical Notified Body AB, INTERTEK SEMKO AB, and INTERTEK SEMKO AB

    ATENA LUX S.R.L.

    Manufacturer
    🇮🇹 Italy·30 Basic UDI-DIs·30 Devices·ITALCERT SRL, ITALCERT SRL, and ITALCERT SRL

    Hamilton Bonaduz AG

    Manufacturer
    🇨🇭 Switzerland·92 Basic UDI-DIs·92 Devices·7 Importers·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·CONTAK RENEWAL 3 CRT-D MODELS H170/H175, CONTAK RENEWAL 3 HE CRT-D MODELS H177/H179, AND MODEL 2845 VERSION 2.2 SOFTWARE

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·EPIC AND ATLAS+ HF CRT-D SYSTEMS

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·CONTAK CD (MODEL 1823), CONTAK CD2 (MODEL H115, H119), RENEWAL (MODELS H135) AND RENEWAL 3 (MODELS H170,H175,H177,H179)

    BETATEX SPA

    Manufacturer
    🇮🇹 Italy·9 Basic UDI-DIs·9 Devices·ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

    JIANGSU JIELE MEDICAL DRESSING CO.,LTD

    Manufacturer
    🇨🇳 China·12 Basic UDI-DIs·28 Devices·2 Importers·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

    Takagi seiko

    Manufacturer
    🇯🇵 Japan·14 Basic UDI-DIs·29 Devices·4 Importers·SGS Belgium NV, SGS FIMKO OY, SGS FIMKO OY, and SGS FIMKO OY

    D1096300016

    Certificate
    MDD Annex V·Active Optical Systems Ltd·MDC MEDICAL DEVICE CERTIFICATION GMBH·2 Basic UDI-DIs

    07290016727043

    Certificate
    MDD Annex V·Active Optical Systems Ltd·MDC MEDICAL DEVICE CERTIFICATION GMBH·1 Basic UDI-DI

    MedNet EC-REP IIb GmbH

    Authorized representative
    🇩🇪 Germany·32 Manufacturers·165 Devices

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·CONTAK RENEWAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)

    QS MEDICAL DEVICE REGISTRATION LTD

    Authorized representative
    🇨🇾 Cyprus·2 Manufacturers·10 Devices

    PROHS Equipamento Hospitalar e Serviços Associados S.A.

    Manufacturer
    🇵🇹 Portugal·45 Basic UDI-DIs·92 Devices·SGS Belgium NV, SGS Belgium NV, SGS Belgium NV, and SGS Belgium NV

    Panin Srl

    Manufacturer
    🇮🇹 Italy·8 Basic UDI-DIs·8 Devices·BUREAU VERITAS ITALIA S.P.A., ISTITUTO SUPERIORE DI SANITA', KIWA CERMET ITALIA S.P.A., and KIWA CERMET ITALIA S.P.A.

    Jafron Biomedical Co., Ltd.

    Manufacturer
    🇨🇳 China·25 Basic UDI-DIs·49 Devices·4 Importers·TÜV Rheinland LGA Products GmbH, TÜV SÜD Product Service GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

    Vertex-Dental B.V.

    Manufacturer
    🇳🇱 Netherlands·30 Basic UDI-DIs·51 Devices·SGS Belgium NV, SGS Belgium NV, SGS Belgium NV, and SGS Belgium NV

    Oclean AirPump Nozzle(N20, N21)

    FDA registration
    Shenzhen Yunding Information Technology Co.,Ltd.·1 product·🇨🇳 China