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

Biomime™ Branch

Meril Life Sciences Pvt. Ltd. · 🇮🇳 India
Devices (same UDI-DI)
1
Certificates
2
Countries
7
Notified Bodies
2

Basic Information

Primary DI
18904224914244
Basic UDI-DI Code
B-18904224914244
Reference
BBR40035019
Device Types
Single use Sterile
Regulation
Eu Mdd
Classification
Eu Md Class 3
Status
On The Market

Additional Description

The BioMime™ Branch Sirolimus Eluting Coronary Side Branch 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 outer platinum iridium radio opaque marker bands.

CND Nomenclature Codes

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

Certificates

Type Number
MDD Annex II Section 4 1783-MDD-113
MDD Annex II (excluding section 4) 1783-MDD-112

Available In Countries

🇩🇪 Germany 🇪🇪 Estonia 🇪🇸 Spain 🇭🇺 Hungary 🇮🇹 Italy 🇵🇱 Poland 🇹🇷 Türkiye

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