BEUDAMED
    22 results · 19ms · Sources: EU EUDAMED, US FDA

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    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

    GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / Dismount, c) 850 3/8 inch NM Gantry, d) 860 / Dismount, e) 860 3/8 inch NM Gantry, f) 860 5/8 inch NM Gantry, g) 860 BJ, h) NM 830 3/8 inch BJ, i) NM/CT 850 3/8 inch BJ, j) NM/CT 850 3/8 inch ROW, k) NM/CT 850 3/8 inch ROW_, l) NM/CT 850 CT 850 3/8 inch, m) NM/CT 850 ES 3/8 inch, n) NM/CT 850 ES 3/8 inch ROW, o) NM/CT 860 3/8 inch, p) NM/CT 860 3/8 inch BJ, q) NM/CT 860 3/8 inch ROW, r) NM/CT 860 ADVANCE, s) NM/CT 860 advance 3/8 inch NM Gantry, t) NM/CT 860 BEYOND, u) NM/CT 860 beyond 3/8 inch NM Gantry, v) NM/CT 860 China for China, w) NM/CT 860 CT 860 3/8 inch, x) NM/CT 860 ES 3/8 inch, y) NM/CT 860 ES 3/8 inch ROW, z) NM/CT 850 3/8 inch, aa) NM/CT 850 ES 3/8 inch ROW, bb) NM/CT 860 3/8 inch CH, cc) XELERIS 4 DR WORKSTATION; Emission Computed Tomography System

    FDA Enforcement
    Class I ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·February 15, 2023

    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