BEUDAMED
    22 results · 21ms · Sources: EU EUDAMED, US FDA

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    Millenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

    FDA Enforcement
    Class II ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·October 29, 2025

    Stream 17

    Device
    EU MDR · Eu Md Class 3 ·Perflow Medical Ltd.·On the market·7 countries

    Stream XL

    Device
    EU MDR · Eu Md Class 3 ·Perflow Medical Ltd.·On the market·7 countries

    Stream

    Device
    EU MDR · Eu Md Class 3 ·Perflow Medical Ltd.·On the market·8 countries

    BioProtect Balloon Implant System

    Device
    EU MDR · Eu Md Class 3 ·BioProtect·On the market·2 countries

    Cascade L Agile

    Device
    EU MDR · Eu Md Class 3 ·Perflow Medical Ltd.·On the market·7 countries

    Cascade L

    Device
    EU MDR · Eu Md Class 3 ·Perflow Medical Ltd.·On the market·7 countries

    Cascade 17

    Device
    EU MDR · Eu Md Class 3 ·Perflow Medical Ltd.·On the market·8 countries

    Cascade M Agile

    Device
    EU MDR · Eu Md Class 3 ·Perflow Medical Ltd.·On the market·7 countries

    Cascade M

    Device
    EU MDR · Eu Md Class 3 ·Perflow Medical Ltd.·On the market·8 countries

    Bioprotect Balloon Implant System

    Basic UDI-DI
    EU MDR · Eu Md Class 3 ·BioProtect·1 device

    Stream

    Basic UDI-DI
    EU MDR · Eu Md Class 3 ·Perflow Medical Ltd.·3 devices

    Cascade M

    Basic UDI-DI
    EU MDR · Eu Md Class 3 ·Perflow Medical Ltd.·5 devices

    Perflow Medical Ltd.

    Manufacturer
    🇮🇱 Israel·5 Importers·DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, and DQS Medizinprodukte GmbH

    Perflow Medical Ltd.

    Manufacturer
    🇮🇱 Israel·11 Basic UDI-DIs·21 Devices·5 Importers·DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, and DQS Medizinprodukte GmbH

    BioProtect

    Manufacturer
    🇮🇱 Israel·2 Basic UDI-DIs·2 Devices·1 Importer·DEKRA Certification B.V. and DEKRA Certification B.V.

    1000169818

    Certificate
    MDR QMS·Perflow Medical Ltd.·DQS Medizinprodukte GmbH

    170783435

    Certificate
    MDR Technical Documentation·Perflow Medical Ltd.·DQS Medizinprodukte GmbH

    170781760

    Certificate
    MDR Technical Documentation·Perflow Medical Ltd.·DQS Medizinprodukte GmbH

    542544 MDR2017P

    Certificate
    MDR Technical Documentation·Perflow Medical Ltd.·DQS Medizinprodukte GmbH·1 Basic UDI-DI