BEUDAMED
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    Fujirebio Europe N.V.

    Authorized representative
    🇧🇪 Belgium·3 Manufacturers

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·KAPPA 700/600,650,800/900 FAMILY, SIGMA FAMILY, MEDTRONIC 350 SERIES, ENPILSE 2 FAMILY ENRHYTHM, ADAPTA/VERSA/SESIA FAM

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·ENDOLOGIX POWERLINK SYSTEM

    Fab, Fitc, Antigen, Antiserum, Control

    FDA classification
    FDA Class 1 ·Fab, Fitc, Antigen, Antiserum, Control

    Fat Reducing Low Level Laser

    FDA classification
    FDA Class 2 ·Fat Reducing Low Level Laser

    Fab, Rhodamine, Antigen, Antiserum, Control

    FDA classification
    FDA Class 1 ·Fab, Rhodamine, Antigen, Antiserum, Control

    Serum Amyloid A (SAA) Kit (Latex Particle-Enhanced Immunonephelometry Method)

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·2 devices

    Replacer, Ureteral

    FDA classification
    FDA Class 3 ·Replacer, Ureteral

    Igg, Peroxidase, Antigen, Antiserum, Control

    FDA classification
    FDA Class 2 ·Igg, Peroxidase, Antigen, Antiserum, Control

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·AORFIX FLEXIBLE STENT GRAFT SYSTEM

    Igg (Fab Fragment Specific), Antigen, Antiserum, Control

    FDA classification
    FDA Class 1 ·Igg (Fab Fragment Specific), Antigen, Antiserum, Control

    Synergy Health Ireland Ltd

    FDA registration
    Synergy Health Ireland Ltd·7 products·🇮🇪 Ireland

    Lake Region Medical

    FDA registration
    Lake Region Medical·7 products·🇺🇸 United States

    Synergy Health Sterilisation UK Ltd

    FDA registration
    Synergy Health Sterilisation UK Ltd·7 products·🇬🇧 United Kingdom

    Isomedix Operations, Inc.

    FDA registration
    Isomedix Operations, Inc.·7 products·🇺🇸 United States

    LAKE REGION MEDICAL LIMITED

    FDA registration
    LAKE REGION MEDICAL LIMITED·7 products·🇮🇪 Ireland

    FAC

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·TECO Medical Instruments, Production + Trading GmbH·1 device

    FAC

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·TECO Medical Instruments, Production + Trading GmbH·1 device

    FAC

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·TECO Medical Instruments, Production + Trading GmbH·1 device

    FAC

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·TECO Medical Instruments, Production + Trading GmbH·1 device