Eu Mdd Eu Md Class 2a On The Market 🇮🇳 India

Mozec™ PTA 0.035" OTW

Meril Life Sciences Pvt. Ltd. · 🇮🇳 India
Devices (same UDI-DI)
1
Certificates
1
Countries
11
Notified Bodies
1

Basic Information

Primary DI
18906029359121
Basic UDI-DI Code
B-18906029359121
Reference
MO35060040B
Device Types
Single use Sterile
Regulation
Eu Mdd
Classification
Eu Md Class 2a
Status
On The Market

Additional Description

Mozec™ PTA OTW Balloon Dilatation Catheter consists of a Balloon (dilatation element) near the distal tip with radiopaque marker bands, which represent the approximate balloon working length at nominal pressure. The proximal end has a Y luer hub for balloon inflation. The catheter has a soft tip at the distal end. Dual lumens shaft which permit movement of guide wire and balloon inflation. The distal portion of the shaft has hydrophilic coating applied on it, in order to facilitate catheter advancing through the vascular district and the vessel stenosis.The compliance chart on the inner and outer label indicates how the balloon diameter increases with increasing pressure. The compliance data is based on in vitro testing of balloons at 37°C temperature. Guide wire compatibility: 0.035”. The Mozec PTA Balloon Dilatation Catheter is available in different balloon sizes. Nominal balloon diameters and lengths are printed on the hub.

CND Nomenclature Codes

Code Description
C010401020101 PTCA BALLOON DILATION CATHETERS

Certificates

Type Number
MDD Annex II (excluding section 4) 261394-2018-CE-IND-NA-PS

Available In Countries

🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇾 Cyprus 🇨🇿 Czechia 🇩🇪 Germany 🇪🇸 Spain 🇭🇷 Croatia 🇭🇺 Hungary 🇮🇹 Italy 🇱🇹 Lithuania 🇹🇷 Türkiye

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