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

Biomime™ Morph

Meril Life Sciences Pvt. Ltd. · 🇮🇳 India
Devices (same UDI-DI)
1
Certificates
2
Countries
18
Notified Bodies
2

Basic Information

Primary DI
18904224901329
Basic UDI-DI Code
B-18904224901329
Reference
BIM27522560
Device Types
Single use Sterile
Regulation
Eu Mdd
Classification
Eu Md Class 3
Status
On The Market

Additional Description

The Biomime™ Morph 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 Tapered 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-333/2021
MDD Annex II (excluding section 4) 1434-MDD-334/2021

Available In Countries

🇧🇬 Bulgaria 🇨🇾 Cyprus 🇨🇿 Czechia 🇩🇪 Germany 🇪🇪 Estonia 🇪🇸 Spain 🇫🇮 Finland 🇭🇷 Croatia 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇹 Italy 🇱🇹 Lithuania 🇳🇱 Netherlands 🇵🇱 Poland 🇵🇹 Portugal 🇸🇪 Sweden 🇸🇰 Slovakia 🇹🇷 Türkiye

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