BEUDAMED
    Eu Mdd Eu Md Class 3 On The Market 🇮🇳 India

    BioMime Aura™

    Meril Life Sciences Pvt. Ltd. · 🇮🇳 India
    View on EUDAMED
    Devices (same UDI-DI)
    1
    Certificates
    2
    Countries
    22
    Notified Bodies
    2

    Basic Information

    Primary DI
    18906029357431
    Basic UDI-DI Code
    B-18906029357431
    Reference
    BIA25032
    Device Types
    Single use Sterile
    Regulation
    Eu Mdd
    Classification
    Eu Md Class 3
    Status
    On The Market
    Manufacturer
    Meril Life Sciences Pvt. Ltd.

    Additional Description

    The BioMime™ Sirolimus Eluting Stent System comprises of following components -A balloon-expandable L605 Cobalt Chromium Coronary Stent -A stent coating that consists of a blend of anti-proliferative drug and polymers 1. Anti-proliferative drug Sirolimus (also known as Rapamycin) 2. Bio-compatible, bio-degradable co-polymer coating which acts as drug reservoir and drug release platform -A rapid-exchange stent delivery PTCA balloon catheter -The stent is pre mounted on balloon catheter & placed between two platinum-iridium radio opaque markers bands.

    CND Nomenclature Codes

    Code Description
    P070402010301 CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS

    Certificates

    Type Number
    MDD Annex II Section 4 1434-MDD-331/2021
    MDD Annex II (excluding section 4) 1434-MDD-332/2021

    Available In Countries

    🇦🇹 Austria 🇧🇬 Bulgaria 🇨🇾 Cyprus 🇨🇿 Czechia 🇩🇪 Germany 🇩🇰 Denmark 🇪🇪 Estonia 🇬🇷 Greece 🇪🇸 Spain 🇫🇮 Finland 🇭🇷 Croatia 🇭🇺 Hungary 🇮🇹 Italy 🇱🇹 Lithuania 🇱🇻 Latvia 🇲🇹 Malta 🇳🇱 Netherlands 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇸🇮 Slovenia 🇸🇰 Slovakia

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