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

    Sapphire NC

    OrbusNeich Medical, B.V. ยท ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands
    View on EUDAMED
    Devices (same UDI-DI)
    1
    Certificates
    1
    Countries
    28
    Notified Bodies
    1

    Basic Information

    Primary DI
    08717853292835
    Basic UDI-DI Code
    B-08717853292835
    Reference
    235-083-2
    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 Sapphire NC Coronary Dilatation Catheter is designed to allow easy exchange of the catheter using a standard length guide wire. Balloon diameters range from 2.0 mm to 5.0 mm. The balloon material is made of a minimally compliant material for diameter 2.0 mm to 5.0 mm with a rated burst pressure (2.0-4.0 mm: 22 atmospheres; 4.5-5.0 mm: 20 atmospheres).

    CND Nomenclature Codes

    Code Description
    C010401020101 PTCA BALLOON DILATION CATHETERS

    Certificates

    Type Number
    MDD Annex II Section 4 CE 649480

    Available In Countries

    ๐Ÿ‡ฆ๐Ÿ‡น Austria 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‡ฎ Finland ๐Ÿ‡ซ๐Ÿ‡ท France ๐Ÿ‡ญ๐Ÿ‡ท Croatia ๐Ÿ‡ญ๐Ÿ‡บ Hungary ๐Ÿ‡ฎ๐Ÿ‡ช Ireland ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ฑ๐Ÿ‡น Lithuania ๐Ÿ‡ฑ๐Ÿ‡บ Luxembourg ๐Ÿ‡ฑ๐Ÿ‡ป Latvia ๐Ÿ‡ฒ๐Ÿ‡น Malta 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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