BEUDAMED
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    Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100

    FDA Enforcement
    Class II ·Terminated·Imactis·March 24, 2021

    VIDAS NT-pro-BNP Product Usage: VIDAS¿ NTproBNP (PBNP) is an automated quantitative test for use on the instruments of the VIDAS family for the determination of N terminal fragment of Btype natriuretic peptide in human serum or plasma (lithium heparin) using the ELFA technique (EnzymeLinked Fluorescent Assay). The VIDAS NTproBNP (PBNP) test is used as an aid in the diagnosis of suspected congestive heart failure.

    FDA Enforcement
    Class III ·Terminated·Biomerieux France Chemin De L'Or·September 21, 2016

    ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, ROTH Catalogue Number 14002 96 S, EOS Imaging Catalogue Number 9000111773; and MOBELI Dual Grip Grab Handle, ROTH Catalogue Number 14002 25 S, EOS Imaging Catalogue Number 9000111774.

    FDA Enforcement
    Class II ·Terminated·EOS Imaging·July 5, 2017

    UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UNiD HUB and the UNiD Spine Analyzer. The UNiD HUB cloud-based software is a healthcare application to receive, transfer, display, store data needed for planning a spine surgery or for post-operative follow-up (patient information, X-ray image and recommendations for planning). The UNiD Spine Analyzer cloud based software is a healthcare application intended for assisting healthcare professionals in viewing and measuring images as well as planning spine surgeries.

    FDA Enforcement
    Class II ·Ongoing·Medicrea International·February 12, 2025

    Loop Dee Science World Wide

    Manufacturer
    🇫🇷 France

    France DAE

    Authorized representative
    🇫🇷 France

    Etoile De L’Europe

    Authorized representative
    🇫🇷 France·1 Manufacturer·5 Devices

    Financière de Participation

    Authorized representative
    🇫🇷 France·2 Manufacturers

    LABORATOIRE BENEWMEDICAL

    Importer
    🇫🇷 France·4 Manufacturers

    Medicare HTM

    Importer
    🇫🇷 France·5 Manufacturers

    SOCIETE DE GESTION MEDICALEX

    Authorized representative
    🇫🇷 France·1 Manufacturer·143 Devices

    Laboratoires Pred

    Importer
    🇫🇷 France·1 Manufacturer

    DEXTER

    Importer
    🇫🇷 France·1 Manufacturer

    LABORATOIRE DE CONTACTOLOGIE APPLIQUEE - LCA

    System producer
    🇫🇷 France

    Apothicom Distribution

    Importer
    🇫🇷 France·1 Manufacturer

    OPHTA-France

    Importer
    🇫🇷 France·8 Manufacturers

    Implicity

    Manufacturer
    🇫🇷 France·3 Basic UDI-DIs·3 Devices

    Contact Sécurité

    Manufacturer
    🇫🇷 France·2 Basic UDI-DIs·10 Devices

    Eurobio Scientific

    Manufacturer
    🇫🇷 France·20 Basic UDI-DIs·44 Devices

    LOGO SILVER

    Manufacturer
    🇫🇷 France