BEUDAMED
    1,110 results · 72ms · Sources: EU EUDAMED, US FDA

    ExoAtlet Global S.A.

    Authorized representative
    🇱🇺 Luxembourg·1 Manufacturer·2 Devices

    ViewMind S.à.r.l.

    Authorized representative
    🇱🇺 Luxembourg·1 Manufacturer

    Promepla Group S.à r.l.

    Authorized representative
    🇱🇺 Luxembourg·1 Manufacturer

    LUXIP SA

    Authorized representative
    🇱🇺 Luxembourg·2 Manufacturers

    KYMCO LUX S.A.

    Authorized representative
    🇱🇺 Luxembourg·1 Manufacturer·7 Devices

    Immunohistochemistry Antibody Assay, C-Kit

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA MEDICAL SYSTEMS PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA PD-L1(SP142) Assay.

    Immunocytochemistry Assay, P16/Ki-67

    FDA Pre-Market Approval
    FDA Class 3 ·CINtec PLUS Cytology

    Ministère de la Santé Direction de la santé Division de la Pharmacie et des Médicament Médical Devices Unit

    Competent authority
    Luxembourg
    25 Manufacturers
    24 Basic UDI-DIs
    139 Devices