BEUDAMED
    Eu Mdd Eu Md Class 3 On The Market ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands

    Combo Plus

    OrbusNeich Medical, B.V. ยท ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands
    View on EUDAMED
    Devices (same UDI-DI)
    1
    Certificates
    1
    Countries
    22
    Notified Bodies
    1

    Basic Information

    Primary DI
    08717853297557
    Basic UDI-DI Code
    B-08717853297557
    Reference
    235-182-11
    Device Types
    Single use Sterile
    Regulation
    Eu Mdd
    Classification
    Eu Md Class 3
    Status
    On The Market
    Manufacturer
    OrbusNeich Medical, B.V.

    Additional Description

    The COMBO Plus Stent is a coronary balloon expandable vascular prosthesis. The COMBO Plus Stent consists of a 316L stainless steel alloy coated with a biocompatible, biodegradable polymer containing sirolimus (also known as rapamycin). Covalently attached to this matrix is a layer of murine, monoclonal, anti-human CD34 antibody. The antibody specifically targets CD34+ cells in circulation. Endothelial progenitor cells (EPCs) are CD34+. This stent is supplied premounted on a delivery catheter.

    CND Nomenclature Codes

    Code Description
    P0704020102 COATED CORONARY STENTS

    Certificates

    Type Number
    MDD Annex II Section 4 CE 649589

    Available In Countries

    ๐Ÿ‡ง๐Ÿ‡ช Belgium ๐Ÿ‡ง๐Ÿ‡ฌ Bulgaria ๐Ÿ‡จ๐Ÿ‡พ Cyprus ๐Ÿ‡จ๐Ÿ‡ฟ Czechia ๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ฉ๐Ÿ‡ฐ Denmark ๐Ÿ‡ช๐Ÿ‡ช Estonia ๐Ÿ‡ฌ๐Ÿ‡ท Greece ๐Ÿ‡ช๐Ÿ‡ธ Spain ๐Ÿ‡ซ๐Ÿ‡ท France ๐Ÿ‡ญ๐Ÿ‡บ Hungary ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ฑ๐Ÿ‡น Lithuania ๐Ÿ‡ฑ๐Ÿ‡ป Latvia ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands ๐Ÿ‡ต๐Ÿ‡ฑ Poland ๐Ÿ‡ต๐Ÿ‡น Portugal ๐Ÿ‡ท๐Ÿ‡ด Romania ๐Ÿ‡ธ๐Ÿ‡ช Sweden ๐Ÿ‡ธ๐Ÿ‡ฎ Slovenia ๐Ÿ‡ธ๐Ÿ‡ฐ Slovakia ๐Ÿ‡น๐Ÿ‡ท Tรผrkiye

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