BEUDAMED
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    Laboratoire Huckert's International

    Manufacturer
    🇧🇪 Belgium·25 Basic UDI-DIs·25 Devices·SGS Belgium NV, SGS Belgium NV, and SGS Belgium NV

    H&O Equipments nv/sa

    Manufacturer
    🇧🇪 Belgium·40 Basic UDI-DIs·40 Devices·SGS Belgium NV and SGS Belgium NV

    Fysiomed NV

    Manufacturer
    🇧🇪 Belgium·4 Basic UDI-DIs·4 Devices·SGS Belgium NV

    Qaelum NV

    Manufacturer
    🇧🇪 Belgium·1 Basic UDI-DI·1 Device·SGS Belgium NV

    MedEnvision bv

    Manufacturer
    🇧🇪 Belgium·2 Basic UDI-DIs·7 Devices·SGS Belgium NV

    CLOUDS OF CARE NV

    Manufacturer
    🇧🇪 Belgium·SGS Belgium NV

    Minze NV

    Manufacturer
    🇧🇪 Belgium·SGS Belgium NV

    Lifestream Pharma N.V.

    Manufacturer
    🇧🇪 Belgium·SGS Belgium NV

    Mondomed NV

    Manufacturer
    🇧🇪 Belgium·1 Basic UDI-DI·76 Devices·SGS Belgium NV

    Hubert De Backer nv

    Manufacturer
    🇧🇪 Belgium·SGS Belgium NV

    NiniX Technologies NV

    Manufacturer
    🇧🇪 Belgium·1 Basic UDI-DI·1 Device·SGS Belgium NV

    icometrix

    Manufacturer
    🇧🇪 Belgium·4 Basic UDI-DIs·6 Devices·SGS Belgium NV

    Roam Technology NV

    Manufacturer
    🇧🇪 Belgium·SGS Belgium NV

    Axinesis

    Manufacturer
    🇧🇪 Belgium·4 Basic UDI-DIs·5 Devices·SGS Belgium NV

    Pfizer Manufacturing Belgium NV

    Manufacturer
    🇧🇪 Belgium·SGS Belgium NV

    Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human samples, using disposable Test-specific ldylla Cartridges.

    FDA Enforcement
    Class II ·Ongoing·Biocartis Nv·January 22, 2025

    Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data . Enterprise Imaging XERO Viewer 8.0.0, 8.0.1, 8.1, 8.1.1, 8.1.2, 8.1.3,8.1.4, 8.2.0.000, 8.2.1.000, 8.2.2.000, 8.3.0.000, 8.3.1.000, 8.3.2.000, 8.4.0.000, 8.4.1.000 (including all SU s and HF s)

    FDA Enforcement
    Class II ·Ongoing·Agfa Healthcare NV·October 16, 2024

    Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as a departmental Picture Archiving and Communications System (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks.

    FDA Enforcement
    Class II ·Terminated·Agfa Healthcare NV·October 17, 2018

    Agfa HealthCare Enterprise Imaging XERO Viewer

    FDA Enforcement
    Class II ·Ongoing·Agfa Healthcare NV·February 1, 2023

    35g N2O Freezpen

    Device
    EU MDD · Eu Md Class 2a ·H&O Equipments nv/sa·On the market·32 countries