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

    Proficient™

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

    Basic Information

    Primary DI
    18904224948508
    Basic UDI-DI Code
    B-18904224948508
    Reference
    PRF222516
    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 Proficient™ Sirolimus Eluting Stent System (Model 2) 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

    🇩🇪 Germany

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