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

MeRes100™

Meril Life Sciences Pvt. Ltd. · 🇮🇳 India
Devices (same UDI-DI)
1
Certificates
2
Countries
5
Notified Bodies
2

Basic Information

Primary DI
18904224914947
Basic UDI-DI Code
B-18904224914947
Reference
MRS27513
Device Types
Single use Sterile
Regulation
Eu Mdd
Classification
Eu Md Class 3
Status
On The Market

Additional Description

The Sirolimus Eluting Bioresorbable Vascular Scaffold System is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to de novo lesion in native coronary arteries in patients eligible for Percutaneous Transluminal Coronary Angioplasty (PTCA) and Scaffolding procedures.The scaffold will eventually resorb and potentially facilitate normalization of vessel function in patients. Covering of minimum 2 mm of non-diseased tissue on either side of the target lesion is recommended. For example, the lesion length may not be more than 15 mm for the scaffold with 19 mm length.

CND Nomenclature Codes

Code Description
P0704020104 CORONARY STENTS, ABSORBABLE

Certificates

Type Number
MDD Annex II Section 4 1783- MDD-119
MDD Annex II (excluding section 4) 1783- MDD-118

Available In Countries

🇩🇪 Germany 🇪🇸 Spain 🇭🇷 Croatia 🇮🇹 Italy 🇳🇱 Netherlands

Similar Devices

Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDD).

View all