BEUDAMED
    24 results · 9ms · Sources: EU EUDAMED, US FDA

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    Route 92 Medical, Inc.

    Manufacturer
    🇺🇸 United States·1 Basic UDI-DI·1 Device·1 Importer·DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, and DQS Medizinprodukte GmbH

    Navbit Pty Ltd

    Manufacturer
    🇦🇺 Australia·2 Basic UDI-DIs·2 Devices·DQS Medizinprodukte GmbH and DQS Medizinprodukte GmbH

    Summus Medical Laser

    Manufacturer
    🇺🇸 United States·2 Basic UDI-DIs·2 Devices·2 Importers·DQS Medizinprodukte GmbH and DQS Medizinprodukte GmbH

    BALT USA LLC

    Manufacturer
    🇺🇸 United States·1 Basic UDI-DI·1 Device·1 Importer·DQS Medizinprodukte GmbH

    Navbit Sprint

    Device
    EU MDD · Eu Md Class 2a ·Navbit Pty Ltd·On the market·1 country

    Navbit Sprint

    Device
    EU MDD · Eu Md Class 2a ·Navbit Pty Ltd·On the market·1 country

    Platinum Series

    Device
    EU MDD · Eu Md Class 2b ·Summus Medical Laser·On the market·4 countries

    XCEL Detachment Controller

    Device
    EU MDD · Eu Md Class 2a ·BALT USA LLC·On the market·32 countries

    Platinum Series

    Device
    EU MDD · Eu Md Class 2b ·Summus Medical Laser·On the market·8 countries

    Tenzing 7

    Device
    EU MDR · Eu Md Class 3 ·Route 92 Medical, Inc.·On the market·4 countries

    XCEL Detachment Controller

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·BALT USA LLC·1 device

    Platinum 4

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·Summus Medical Laser·1 device

    H1

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·Summus Medical Laser·1 device

    Navbit Sprint Device, Supine Registration

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Navbit Pty Ltd·1 device

    Navbit Sprint Device, Lateral Registration

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Navbit Pty Ltd·1 device

    Tenzing 7 Delivery Catheter

    Basic UDI-DI
    EU MDR · Eu Md Class 3 ·Route 92 Medical, Inc.·1 device

    170780332

    Certificate
    MDR Technical Documentation·Route 92 Medical, Inc.·DQS Medizinprodukte GmbH

    170776070

    Certificate
    MDR QMS·Route 92 Medical, Inc.·DQS Medizinprodukte GmbH

    170776241

    Certificate
    MDD Annex II (excluding section 4)·BALT USA LLC·DQS Medizinprodukte GmbH·1 Basic UDI-DI

    170775883

    Certificate
    MDD Annex II (excluding section 4)·Navbit Pty Ltd·DQS Medizinprodukte GmbH·1 Basic UDI-DI