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    Cardinal Health C/O Avarto Benelux BV

    FDA registration
    Cardinal Health C/O Avarto Benelux BV·13 products·🇳🇱 Netherlands

    Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) Azurion 3M12: 722063, 722221; (2) Azurion 3M15: 722064, 722222; (3) Azurion SM12: 722227; (4) Azurion SM20: 722228; (5) Azurion 7B12/12: 722067, 722225; (6) Azurion 7820/15: 722068, 722226; (7) Azurion 7M12: 722078, 722223; (8) Azurion 7M20 : 722079, 722224

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 7, 2023

    Technomed Europe

    Manufacturer
    🇳🇱 Netherlands·457 Basic UDI-DIs·695 Devices·DEKRA Certification B.V. and DEKRA Certification B.V.

    Kingsmead Service B.V.

    Authorized representative
    🇳🇱 Netherlands·243 Manufacturers·2698 Devices

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices

    BSI Group The Netherlands B.V.

    Notified body
    🇳🇱 Netherlands·376 Manufacturers·26587 Basic UDI-DIs

    DEKRA Certification B.V.

    Notified body
    🇳🇱 Netherlands·216 Manufacturers·7327 Basic UDI-DIs

    SUNGO Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·1571 Manufacturers·20390 Devices

    Azurion series

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·Philips Medical Systems Nederland B.V.·1 device

    Azurion series

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·Philips Medical Systems Nederland B.V.·1 device

    Disposable Stimulation Probes and Surgical Instruments

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Technomed Europe·1 device

    Disposable Stimulation Probes and Surgical Instruments

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Technomed Europe·1 device

    Disposable Stimulation Probes and Surgical Instruments

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Technomed Europe·1 device

    Disposable Stimulation Probes and Surgical Instruments

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Technomed Europe·1 device

    Disposable Stimulation Probes and Surgical Instruments

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Technomed Europe·1 device

    Disposable Stimulation Probes and Surgical Instruments

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Technomed Europe·1 device

    Disposable Stimulation Probes and Surgical Instruments

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Technomed Europe·1 device

    Phlecs full body blue

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Phlecs B.V.·1 device

    DEBRIX

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·DEBx Medical BV·1 device

    DEBRIX

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·DEBx Medical BV·1 device